510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K936156Substantially Equivalent

Ventilation Mechanics Monitor Model Vmm-100

Smith Industries Medical Systems (Sims), Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K936156 is the FDA 510(k) clearance record for VENTILATION MECHANICS MONITOR MODEL VMM-100, a class II device, cleared for Smith Industries Medical Systems (Sims) on under FDA product code MOD (Accessory To Continuous Ventilator (Respirator)). FDA records list one 510(k) clearance for Smith Industries Medical Systems (Sims). As of , FDA records show no recalls naming K936156.

Clearance record

Decision date
Received
(547 days to decision)
Product code
MOD Accessory To Continuous Ventilator (Respirator)
Regulation
21 CFR 868.5895
Device class
Class II
Review panel
Anesthesiology
Applicant
Smith Industries Medical Systems (Sims) 2552 Mcgaw Ave., Irvine CA
510(k) summary
Summary
Third party review
No

Clearances, product code MOD

Trailing 12 months
3 clearances under product code MOD in the twelve months to October 2026, August 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code MOD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20262
September 20260
October 20260