510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K914694Substantially Equivalent

Sterile View(tm) Hi Effic Helmet/back Pk Sup/exhau

Depuy, Inc., Warsaw IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K914694 is the FDA 510(k) clearance record for STERILE VIEW(TM) HI EFFIC HELMET/BACK PK SUP/EXHAU, a class II device, cleared for Depuy, Inc. on under FDA product code JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered). FDA records list 220 510(k) clearances for Depuy, Inc., from to . As of , FDA records show no recalls naming K914694.

Clearance record

Decision date
Received
(90 days to decision)
Product code
JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
Regulation
21 CFR 878.4780
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Depuy, Inc. P.O. Box 988, Warsaw IN
510(k) summary
Summary
Third party review
No

Clearances, product code JCX

Trailing 12 months
1 clearance under product code JCX in the twelve months to November 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JCX, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260