510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K953485Substantially Equivalent

Sims CPAP System

Smiths Industries Medical Systems, Inc., Keene NH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K953485 is the FDA 510(k) clearance record for SIMS CPAP SYSTEM, a class II device, cleared for Smiths Industries Medical Systems, Inc. on under FDA product code BYE (Attachment, Breathing, Positive End Expiratory Pressure). FDA records list 22 510(k) clearances for Smiths Industries Medical Systems, Inc., from to . As of , FDA records show no recalls naming K953485.

Clearance record

Decision date
Received
(94 days to decision)
Product code
BYE Attachment, Breathing, Positive End Expiratory Pressure
Regulation
21 CFR 868.5965
Device class
Class II
Review panel
Anesthesiology
Applicant
Smiths Industries Medical Systems, Inc. 15 Kit St., Keene NH
510(k) summary
Summary
Third party review
No

Clearances, product code BYE

Trailing 12 months

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

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