Cleared Traditional

K781699 - EAGLE PAC/VISIBLE SEAL

K781699 is an FDA 510(k) clearance for EAGLE PAC/VISIBLE SEAL, manufactured by American Sterilizer Co.. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K781699 · American Sterilizer Co. · General Hospital
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Oct 1978
Decision
13d
Days
Class 2
Risk

K781699 is an FDA 510(k) clearance for the EAGLE PAC/VISIBLE SEAL. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by American Sterilizer Co. (Walker, US). The FDA issued a Cleared decision on October 24, 1978 after a review of 13 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all American Sterilizer Co. devices

FDA 510(k) Submission Details - K781699

510(k) Number K781699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1978
Decision Date October 24, 1978
Days to Decision 13 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
116d faster than avg
Panel avg: 129d · This submission: 13d
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 171
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K781699.
INSTRUMENT GUARD CAPSULE
K831588 · Treace Medical, Inc. · Jun 1983
DISPOSABLE INSTRUMENT TRAY PAD
K791412 · Anago, Inc. · Aug 1979
DISPOSABLE SURGICAL INSTRUMENT TIP
K782144 · Anago, Inc. · Jan 1979
SURGICAL INSTRUMENT PROTECTOR
K771123 · Devon Industries, Inc. · Oct 1977
INSTRUMENT TRAY PAD
K771124 · Devon Industries, Inc. · Oct 1977
PROTECTOR, SURGICAL INSTRUMENT
K760320 · Devon Industries, Inc. · Sep 1976