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
K854363Substantially Equivalent

Saratoga Sct Heated Humidification System

Saratoga Medical Instrumentation, Inc., Hadley NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854363 is the FDA 510(k) clearance record for SARATOGA SCT HEATED HUMIDIFICATION SYSTEM, a class II device, cleared for Saratoga Medical Instrumentation, Inc. on under FDA product code BTT (Humidifier, Respiratory Gas, (Direct Patient Interface)). FDA records list one 510(k) clearance for Saratoga Medical Instrumentation, Inc. As of , FDA records show no recalls naming K854363.

Clearance record

Decision date
Received
(63 days to decision)
Product code
BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Regulation
21 CFR 868.5450
Device class
Class II
Review panel
Anesthesiology
Applicant
Saratoga Medical Instrumentation, Inc. R.D. 1, Box 131, Hadley NY
Third party review
No

Clearances, product code BTT

Trailing 12 months
5 clearances under product code BTT in the twelve months to October 2026, January 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code BTT, trailing twelve months
MonthClearances
November 20250
December 20251
January 20262
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260