Anesthesiology · 510(k) · 2020
Air Next
NuvoAir AB. Cleared by FDA on 2 January 2020 under submission K183089, product code BZG (spirometer, diagnostic). What FDA's record says, in FDA's words.
Device record · K183089
- Device. Air NextDEVICE
- Company. NuvoAir AB (SE)COMPANY
- Decision. 2 January 2020, 510(k), substantially equivalent (traditional review); received 6 November 2018DECISION
- Panel. AnesthesiologyPANEL
- Product code. BZG, Spirometer, DiagnosticCODE
- Regulation. 21 CFR 868.1840, Class IIREG
- Source. FDA database entry · decision document (10 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.
Air Next is intended to be used by: Healthcare professionals trained to perform spirometry tests on patients of age ≥ 5 years old, > 10 kg and ≥ 110 cm. Air Next is intended to perform basic lung function and spirometry testing. The actual diagnosis shall be done by a healthcare professional in hospital and clinical settings. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a dentist or physician.
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.
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 31 reports filed against devices carrying product code BZG. 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:
25 May 2026 · Malfunction · LOCAL ANESTHESIA CUSTOM PACK (EPIDURAL) · ICU MEDICAL, INC. · report 3012307300-2026-05326
IT WAS REPORTED THAT THREE INSTANCES OF FLUID LEAKAGE OCCURRED FROM WITHIN THE NRFIT SYRINGE PLUNGER. THE EVENT OCCURRED DURING PATIENT USE AT THE FACILITY. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.
21 May 2026 · Malfunction · WELCH ALLYN DIAGNOSTIC CARDIOLOGY SUITE · BAXTER HEALTHCARE CORPORATION · report 1316463-2026-00303
A CUSTOMER CONTACTED TECHNICAL SERVICE TO REPORT THAT THE DIAGNOSTIC CARDIOLOGY SUITE HAD INCORRECT PATIENT INFORMATION PULLED IN WHEN TAKING EXAM THROUGH VERADIGM/ALLSCRIPTS. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.
15 May 2026 · Malfunction · CONTRACT EQ MM-HSCRIBE-DICOM MIDDLEWARE · WELCH ALLYN INC · report 1316463-2026-00038
THE CUSTOMER REPORTED THAT INCORRECT REPORTS WERE AUTO ATTACHING TO THE WRONG PATIENT FILE. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).
1 April 2026 · Malfunction · SMARTCARE CONNECT PREMIUM PLUS - TIER D · WELCH ALLYN INC · report 1316463-2026-00018
THE CUSTOMER REPORTED THAT INCORRECT REPORTS WERE AUTO ATTACHING TO THE WRONG PATIENT FILE. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #: (B)(4).
14 February 2025 · Malfunction · SPIROBANK II · MIR - MEDICAL INTERNATIONAL RESEARCH SPA · report 21383968
PATIENT WITH MUSK (MUSCLE-SPECIFIC KINASE) ANTIBODY POSITIVE MYASTHENIA GRAVIS ADMITTED FOR MYASTHENIA GRAVIS EXACERBATION WITH RESPIRATORY FAILURE. AFTER 2 ATTEMPTS OF OBTAINING PARAMETERS FROM PATIENT, THIS THERAPIST RECOGNIZED THE VALUES WERE UNCHANGING. A SECOND FILTER WAS PLACED, AND THIS THERAPIST ATTEMPTED MANEUVERS AGAIN AND THE SAME RESULTS WERE DISPLAYED ON DEVICE. A SECOND DEVICE WAS USED TO OBTAIN PARAMETERS WHICH WERE REPEATABLE AND SIGNIFICANTLY LESS. DOCUMENTATION: "QUESTIONABLE […]
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 BZG, in Anesthesiology, or cleared in 2020. 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.