510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K880725Substantially Equivalent

Sam(tm) Model One

Sentel Tech. C/O Criticare Systems, Inc., Santee CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K880725 is the FDA 510(k) clearance record for SAM(TM) MODEL ONE, a class II device, cleared for Sentel Tech. C/O Criticare Systems, Inc. on under FDA product code BZQ (Monitor, Breathing Frequency). FDA records list one 510(k) clearance for Sentel Tech. C/O Criticare Systems, Inc. As of , FDA records show no recalls naming K880725.

Clearance record

Decision date
Received
(196 days to decision)
Product code
BZQ Monitor, Breathing Frequency
Regulation
21 CFR 868.2375
Device class
Class II
Review panel
Anesthesiology
Applicant
Sentel Tech. C/O Criticare Systems, Inc. 10054 Prospect Ave., Santee CA
Third party review
No

Clearances, product code BZQ

Trailing 12 months
2 clearances under product code BZQ in the twelve months to October 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code BZQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20262
July 20260
August 20260
September 20260
October 20260