Cleared Traditional

K801393 - AIR ASPIRATOR NEEDLE

K801393 is an FDA 510(k) clearance for AIR ASPIRATOR NEEDLE, manufactured by Texas Medical Products, Inc.. The device is a Class 1 Cardiovascular device with product code DWS cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K801393 · Texas Medical Products, Inc. · Cardiovascular device
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Jun 1980
Decision
17d
Days
Class 1
Risk

K801393 is an FDA 510(k) clearance for the AIR ASPIRATOR NEEDLE. Classified as Instruments, Surgical, Cardiovascular (product code DWS), Class I - General Controls.

Submitted by Texas Medical Products, Inc. (Walker, US). The FDA issued a Cleared decision on June 30, 1980 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4500 - the FDA cardiovascular device oversight 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.

FDA 510(k) Submission Details - K801393

510(k) Number K801393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1980
Decision Date June 30, 1980
Days to Decision 17 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 125d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

DWS Device Classification - Class 1, General Controls

Product Code DWS Instruments, Surgical, Cardiovascular
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.4500
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 - DWS Instruments, Surgical, Cardiovascular

All 70
Devices cleared under the same product code (DWS) and FDA review panel - the closest regulatory comparables to K801393.
VENOUS CANNULA TRAY
K813284 · Cunningham Woodland, Inc. · Dec 1981
NEOLOOPS
K810890 · Medical Marketing Systems · Aug 1981
DEKNATEL GOOSEN VASCULAR PUNCH BLADES
K802079 · Howmedica Corp. · Sep 1980
HANCOCK AORTIC PUNCH
K800122 · Hancock Laboratories, Inc. · Feb 1980
CASTROVIEJO VASCULAR SCISSORS
K792576 · Edward Weck, Inc. · Dec 1979
AORTIC OCCLUDER #000390
K792088 · Edward Weck, Inc. · Oct 1979
K801393 · AIR ASPIRATOR NEEDLE
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