510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K864886Substantially Equivalent

Respigraph-Respisomnograph-Respicentral

Nims/Respitrace Corp., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864886 is the FDA 510(k) clearance record for RESPIGRAPH-RESPISOMNOGRAPH-RESPICENTRAL, a class II device, cleared for Nims/Respitrace Corp. on under FDA product code BZK (Spirometer, Monitoring (W/Wo Alarm)). FDA records list one 510(k) clearance for Nims/Respitrace Corp. As of , FDA records show no recalls naming K864886.

Clearance record

Decision date
Received
(84 days to decision)
Product code
BZK Spirometer, Monitoring (W/Wo Alarm)
Regulation
21 CFR 868.1850
Device class
Class II
Review panel
Anesthesiology
Applicant
Nims/Respitrace Corp. 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