Anesthesiology · 510(k) · 2025
Personalized Therapy Comfort Settings (PTCS)
ResMed Corp. Cleared by FDA on 5 December 2025 under submission K251657, product code BZD (ventilator, non-continuous (respirator)). What FDA's record says, in FDA's words.
Device record · K251657
- Device. Personalized Therapy Comfort Settings (PTCS)DEVICE
- Company. ResMed CorpCOMPANY
- Decision. 5 December 2025, 510(k), substantially equivalent (traditional review); received 30 May 2025DECISION
- Panel. AnesthesiologyPANEL
- Product code. BZD, Ventilator, Non-Continuous (Respirator)CODE
- Regulation. 21 CFR 868.5905, 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.
Personalized Therapy Comfort Settings (“PTCS”) is an optional software accessory indicated for use by healthcare professionals and patients, providing recommended non-prescription comfort settings options to support patients when using their compatible Resmed PAP therapy device. The outputs provided by PTCS are optional recommendations and are not required to use the therapy device. It is intended for use in a home or clinical environment.
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 304,206 reports filed against devices carrying product code BZD. 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:
30 September 2026 · Malfunction · REMstar Pro C-Flex+ · Respironics, Inc. · report 2518422-2026-046577
A REMstar Pro C-Flex+ device was returned to a third-party service center for service as part of the sound abatement foam recall process. During the evaluation of the device, the service technician observed visible foam particles. During the evaluation, there was dust contamination found in the device. The device was scrapped.
30 September 2026 · Malfunction · REMstar Auto · Respironics, Inc. · report 2518422-2026-046567
A REMstar Auto device was returned to a third-party service center for service as part of the sound abatement foam recall process. During the evaluation of the device, the service technician observed visible foam particles. During the evaluation, there was dust contamination found in the device. The device was scrapped.
30 September 2026 · Malfunction · DreamStation · Respironics, Inc. · report 2518422-2026-046619
A DreamStation Auto CPAP device was returned to a third-party service center with no initial alleged complaint. There was no report of serious or permanent harm or injury. There was no report of medical intervention.During the evaluation of the device at the third-party service center, the device was visually inspected, and evidence of foam degradation/particles was found inside the blower kit and found blower foam degradation.Additionally, the service technician also noted dust contamination. […]
30 September 2026 · Malfunction · REMstar System One 60 Series · Respironics, Inc. · report 2518422-2026-045458
This notification was opened for review for information received that the REMstar Auto A-Flex device was returned to a third-party service center in reference to the voluntary safely notice/recall notification related to the sound abatement foam in certain CPAP, BIPAP and mechanical ventilator device.During evaluation no foam particle were noted in the airpath, yet foam degradation was noted. The device sound abatement foam needs to be replaced to address the issue.Additionally, the service […]
30 September 2026 · Malfunction · DreamStation · Respironics, Inc. · report 2518422-2026-046622
A DreamStation Auto CPAP device was returned to a third-party service center with no initial alleged complaint. There was no report of serious or permanent harm or injury. There was no report of medical intervention.During the evaluation of the device at the third-party service center, the device was visually inspected, and evidence of foam degradation/particles was found inside the blower kit and also noted blower foam degradation.Additionally, the service technician found dust contamination. […]
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 BZD, in Anesthesiology, 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.