Neurology · 510(k) · 2025
Falcon HST
Compumedics Limited. Cleared by FDA on 20 February 2025 under submission K242447, product code OLV (standard polysomnograph with electroencephalograph). What FDA's record says, in FDA's words.
Device record · K242447
- Device. Falcon HSTDEVICE
- Company. Compumedics Limited (AU)COMPANY
- Decision. 20 February 2025, 510(k), substantially equivalent (traditional review); received 16 August 2024DECISION
- Panel. NeurologyPANEL
- Product code. OLV, Standard Polysomnograph With ElectroencephalographCODE
- Regulation. 21 CFR 882.1400, Class IIREG
- Source. FDA database entry · decision document (11 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
, results of technological, performance & safety testing and a comparison to the predicate devices, it is concluded that the Falcon HST system with Profusion Sleep 5.1 feature support is substantially equivalent to the Zmachine Synergy and Zmachine DT-100, and there are no new issues identified in terms of safety or effectiveness with respect to its intended use. T he below table contains a multi-parameter comparison between Falcon HST system with Profusion Sleep 5.1 support feature, the primary predicate device the Zmachine Synergy and the predicate device Zmachine DT -100. This table is included in AJ056 Falcon Substantial Equivalence Discussion with further analysis of differences where applicable. Characteristic Falcon HST Zmachine Synergy (Primary
The product code's definition, from FDA's classification record. Acquire, display, store, and archive electroencephalographic signals from the brain and other signals (such as electromyography, respiratory and/or oximetry signals) for sleep recordings. May also be used to allow on-screen review, user-controlled annotation and user-controlled marking of data.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsnone of the tracked terms matched
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 21 reports filed against devices carrying product code OLV. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
13 May 2026 · Malfunction · BRAIN MONITOR WHT-REFURB · NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. · report 9612330-2026-00001
POWER CORD/PLUG FROM THE UPS CAUGHT FIRE. IT HAS SCORCH MARKS AND MELTING AROUND THE CORD. NO INJURIES.
29 October 2025 · Malfunction · ALICE 6 · RESPIRONICS, INC. · report 2518422-2025-050122
THE MANUFACTURER RECEIVED INFORMATION FROM CUSTOMER IN REFERENCE TO A ALICE 6, BASE STATION SYSTEM, NO ALLEGATION REPORTED BY THE PATIENT. THERE WAS NO REPORT OF SERIOUS INJURY OR HARM. THERE IS NO MEDICAL INTERVENTION WAS SPECIFIED. THE DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER. DURING EVALUATION IT WAS OBSERVED THE SBC WITH ELECTRICAL DAMAGE AND ADDITIONAL FAILURES OBSERVED HARD DISK FRONT, RIGHT LEFT COVER WITH PHYSICAL DAMAGE. THERE WAS ONE ERROR HAS BEEN IDENTIFIED AND UNIT […]
26 June 2024 · Malfunction · ALICE 6 · RESPIRONICS, INC. · report 2518422-2024-39550
THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE/RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION EYE IRRITATION, NOSE IRRITATION, SKIN IRRITATION, RESPIRATORY TRACT IRRITATION, DIZZINESS AND/OR HEADACHE, NAUSEA / VOMITING. THERE WAS REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURE FOR EVALUATION. AT THIS TIME, NO […]
23 April 2024 · Malfunction · ALICE 6, LDXS HEADBOX · RESPIRONICS, INC. · report 2518422-2024-21857
THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT WHILE A CUSTOMER WAS PLUGGING IN AN ALICE 6 HEAD BOX, THEY RECEIVED A SHOCK. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
8 August 2023 · Malfunction · EMBLETTA MPR PG · NATUS MEDICAL INCORPORATED · report 17479681
THE PULSE OXIMETER DURING PATIENT'S HOME SLEEP STUDY FAILED TO TURN ON FOR THE PATIENT AT HOME. PATIENT DID WEAR THE HOME SLEEP TEST ANYWAY, BUT BECAUSE THERE WAS NO OXIMETRY READING THE PATIENT HAD TO REPEAT THE TEST. AFTER SPEAKING WITH THE DIRECTOR OF SLEEP CENTER, SHE REPORTED THIS IS THE 3RD OXIMETER, OF THIS TYPE, THAT HAS FAILED TO TURN ON DURING A STUDY.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code OLV, in Neurology, or cleared in 2025. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.