Cleared Traditional

K771124 - INSTRUMENT TRAY PAD

K771124 is an FDA 510(k) clearance for INSTRUMENT TRAY PAD, manufactured by Devon Industries, Inc.. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K771124 · Devon Industries, Inc. · General Hospital
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Oct 1977
Decision
128d
Days
Class 2
Risk

K771124 is an FDA 510(k) clearance for the INSTRUMENT TRAY PAD. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Devon Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 28, 1977 after a review of 128 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - 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 Devon Industries, Inc. devices

FDA 510(k) Submission Details - K771124

510(k) Number K771124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1977
Decision Date October 28, 1977
Days to Decision 128 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 129d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KCT Device Classification - Class 2, Special Controls

Product Code KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
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 - KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

All 165
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K771124.
DISPOSABLE SURGICAL INSTRUMENT TIP
K782144 · Anago, Inc. · Jan 1979
EAGLE PAC/VISIBLE SEAL
K781699 · American Sterilizer Co. · Oct 1978
SURGICAL INSTRUMENT PROTECTOR
K771123 · Devon Industries, Inc. · Oct 1977
PROTECTOR, SURGICAL INSTRUMENT
K760320 · Devon Industries, Inc. · Sep 1976