Cleared Special

K994053 - STRYKER T4 POWER PACK

K994053 is the FDA 510(k) clearance for STRYKER T4 POWER PACK by Stryker Instruments. It is a Class 2 General Hospital device (product code FYA) cleared through the Special 510(k) pathway after a 20-day FDA review.

K994053 · Stryker Instruments · General Hospital
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Dec 1999
Decision
20d
Days
Class 2
Risk

K994053 is an FDA 510(k) clearance for the STRYKER T4 POWER PACK, STRYKER T4 EIGHT STATION BATTERY CHARGER, STRYKER T4 C.... Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on December 20, 1999 after a review of 20 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Stryker Instruments devices

Submission Details

510(k) Number K994053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1999
Decision Date December 20, 1999
Days to Decision 20 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 129d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

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 147
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K994053.
MODIFICATION TO CONVERTORS SURGICAL GOWNS
K001189 · Allegiance Healthcare Corp. · Apr 2000
MEDLINE BREATHABLE, IMPERVIOUS DISPOSABLE SURGICAL GOWNS
K993170 · Medline Industries, Inc. · Mar 2000
CONVERTORS SURGICAL GOWNS, STERILE
K994244 · Allegiance Healthcare Corp. · Feb 2000
STRYKER T4 HOOD, STRYKER T4 ZIPPERED TOGA, STRYKER T4 PULLOVER TOGA
K993148 · Stryker Instruments · Oct 1999
CONVERTORS SURGICAL GOWNS
K992951 · Allegiance Healthcare Corp. · Sep 1999
CONVERTORS BREATHABLE SURGICAL GOWNS
K992514 · Allegiance Healthcare Corp. · Aug 1999