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
K943146Substantially Equivalent

Porta-Resp Monitor

S & M Instrument Co., Doylestown PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K943146 is the FDA 510(k) clearance record for PORTA-RESP MONITOR, a class II device, cleared for S & M Instrument Co. on under FDA product code CAP (Monitor, Airway Pressure (Includes Gauge And/Or Alarm)). FDA records list 4 510(k) clearances for S & M Instrument Co., from to . As of , FDA records show no recalls naming K943146.

Clearance record

Decision date
Received
(151 days to decision)
Product code
CAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
Regulation
21 CFR 868.2600
Device class
Class II
Review panel
Anesthesiology
Applicant
S & M Instrument Co. 202 Airport Blvd., Doylestown PA
510(k) summary
Summary
Third party review
No

Clearances, product code CAP

Trailing 12 months

FDA records hold no clearances under product code CAP in the trailing twelve months.

FDA records show no clearances under product code CAP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CAP, 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 20260
October 20260