Cleared Traditional

K801964 - CUSTOM LYMPHANGIOGRAM ACCES. PACK-STERI

K801964 is an FDA 510(k) clearance for CUSTOM LYMPHANGIOGRAM ACCES. PACK-STERI, manufactured by American Pharmaseal Div. Ahsc. The device is a Class 1 General & Plastic Surgery device with product code FSM cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K801964 · American Pharmaseal Div. Ahsc · General & Plastic Surgery device
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Oct 1980
Decision
52d
Days
Class 1
Risk

K801964 is an FDA 510(k) clearance for the CUSTOM LYMPHANGIOGRAM ACCES. PACK-STERI. Classified as Tray, Surgical, Instrument (product code FSM), Class I - General Controls.

Submitted by American Pharmaseal Div. Ahsc (Mchenry, US). The FDA issued a Cleared decision on October 10, 1980 after a review of 52 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery 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 Pharmaseal Div. Ahsc devices

FDA 510(k) Submission Details - K801964

510(k) Number K801964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1980
Decision Date October 10, 1980
Days to Decision 52 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 115d · This submission: 52d
Pathway characteristics
Predicate-based equivalence.

FSM Device Classification - Class 1, General Controls

Product Code FSM Tray, Surgical, Instrument
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FSM Tray, Surgical, Instrument

All 21
Devices cleared under the same product code (FSM) and FDA review panel - the closest regulatory comparables to K801964.
AMPCO-DRESSING CHANGE TRAY-MAJOR DC 7418
K802965 · Associated Medical Products Co. · Jan 1981
AUXILIARY TRAY
K802088 · American Pharmaseal Div. Ahsc · Nov 1980
A.M.P.C.O. SKIN SCRUB TRAY
K802570 · Associated Medical Products Co. · Nov 1980
CUSTOM UNIVERSAL CUTDOWN PREP TRAY
K801965 · American Pharmaseal Div. Ahsc · Oct 1980
MICRO CLIP STERILIZING CASE #65199
K801470 · Edward Weck, Inc. · Jul 1980
MICRESURGICAL TRAY, SM.,MED., & LG.
K800367 · Edward Weck, Inc. · Mar 1980