Cleared Traditional

K781264 - PAB CONVENIENCE TRAY

K781264 is an FDA 510(k) clearance for PAB CONVENIENCE TRAY, manufactured by Waters Assoc., Inc.. The device is a Class 1 General & Plastic Surgery device with product code GAA cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K781264 · Waters Assoc., Inc. · General & Plastic Surgery device
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Sep 1978
Decision
58d
Days
Class 1
Risk

K781264 is an FDA 510(k) clearance for the PAB CONVENIENCE TRAY. Classified as Needle, Aspiration And Injection, Disposable (product code GAA), Class I - General Controls.

Submitted by Waters Assoc., Inc. (Mchenry, US). The FDA issued a Cleared decision on September 20, 1978 after a review of 58 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 Waters Assoc., Inc. devices

FDA 510(k) Submission Details - K781264

510(k) Number K781264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1978
Decision Date September 20, 1978
Days to Decision 58 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 115d · This submission: 58d
Pathway characteristics
Predicate-based equivalence.

GAA Device Classification - Class 1, General Controls

Product Code GAA Needle, Aspiration And Injection, Disposable
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 - GAA Needle, Aspiration And Injection, Disposable

All 73
Devices cleared under the same product code (GAA) and FDA review panel - the closest regulatory comparables to K781264.
NEEDLE, WITH FILTER
K790142 · National Patent Development Corp. · Feb 1979
NEEDLE, BURRON FILTER
K790061 · National Patent Development Corp. · Feb 1979
NEEDLE, BLOOD COLLECTING
K790079 · Jelco Laboratories · Feb 1979
BONE MARROW ASPIRATION KIT
K781371 · Ferris Mfg. Corp. · Sep 1978
IMPROVED DISPOSABLE HYPODERMIC NEEDLE
K780887 · Pharmaseal Div., Baxter Healthcare Corp. · Jun 1978
CULDOCENTESIS TRAY
K780624 · Cutter Laboratories, Inc. · May 1978