510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K170663Substantially Equivalent

Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer

Foremount Enterprise Co., Ltd., Taichung City, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K170663 is the FDA 510(k) clearance record for Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer, a class II device, cleared for Foremount Enterprise Co., Ltd. on under FDA product code BTM (Ventilator, Emergency, Manual (Resuscitator)). FDA records list one 510(k) clearance for Foremount Enterprise Co., Ltd. As of , FDA records show no recalls naming K170663.

Clearance record

Decision date
Received
(431 days to decision)
Product code
BTM Ventilator, Emergency, Manual (Resuscitator)
Regulation
21 CFR 868.5915
Device class
Class II
Review panel
Anesthesiology
Applicant
Foremount Enterprise Co., Ltd. # 17, Aly. 15, Ln. 5, Shenan St., Shengang Dist.,, Taichung City, TW
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BTM

Trailing 12 months
1 clearance under product code BTM in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code BTM, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260