Cleared Traditional

K132386 - TOTALSHIELD SURGICAL HELMET SYSTEM

K132386 is the FDA 510(k) clearance for TOTALSHIELD SURGICAL HELMET SYSTEM by Zimmer, Inc.. It is a Class 2 General Hospital device (product code FYA) cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K132386 · Zimmer, Inc. · General Hospital
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Dec 2013
Decision
144d
Days
Class 2
Risk

K132386 is an FDA 510(k) clearance for the TOTALSHIELD SURGICAL HELMET SYSTEM. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Zimmer, Inc. (Indianpolis, US). The FDA issued a Cleared decision on December 23, 2013 after a review of 144 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Zimmer, Inc. devices

Submission Details

510(k) Number K132386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2013
Decision Date December 23, 2013
Days to Decision 144 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 129d · This submission: 144d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FYA Gown, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FYA Gown, Surgical

All 128
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K132386.
TOTAL SHIELD SURGICAL
K142166 · Zimmer, Inc. · Aug 2014
STRYKER STERI-SHIELD FLYTE HYBRID TOGAS
K141095 · Stryker Corporation · Aug 2014
T4/T5 HYTREL TOGAS
K121664 · Stryker Corporation · Mar 2014
MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNS
K103406 · Kimberly-Clark Corp. · Dec 2010
KIMBERLY-CLARK KC100 SURGICAL GOWN, MODEL KC100
K093115 · Kimberly-Clark Corp. · Mar 2010
MICROCOOL SURGICAL GOWN, BREATHABLE HIGH PERFORMANCE KC400
K091357 · Kimberly-Clark Corp. · Aug 2009