510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K884959Substantially Equivalent

Respitrak

Non-Invasive Monitoring Systems, Inc., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K884959 is the FDA 510(k) clearance record for RESPITRAK, a class II device, cleared for Non-Invasive Monitoring Systems, Inc. on under FDA product code BZK (Spirometer, Monitoring (W/Wo Alarm)). FDA records list 6 510(k) clearances for Non-Invasive Monitoring Systems, Inc., from to . As of , FDA records show no recalls naming K884959.

Clearance record

Decision date
Received
(191 days to decision)
Product code
BZK Spirometer, Monitoring (W/Wo Alarm)
Regulation
21 CFR 868.1850
Device class
Class II
Review panel
Anesthesiology
Applicant
Non-Invasive Monitoring Systems, Inc. Dickstein, Shapiro & Morin, Washington DC
Third party review
No

Clearances, product code BZK

Trailing 12 months
1 clearance under product code BZK in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code BZK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260