Cleared Traditional

K830381 - STERILE SAFETY PINS

K830381 is an FDA 510(k) clearance for STERILE SAFETY PINS, manufactured by Devon Industries, Inc.. The device is a Class 2 General Hospital device with product code GAZ cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K830381 · Devon Industries, Inc. · General Hospital
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Mar 1983
Decision
48d
Days
Class 2
Risk

K830381 is an FDA 510(k) clearance for the STERILE SAFETY PINS. Classified as Tubing, Noninvasive (product code GAZ), Class II - Special Controls.

Submitted by Devon Industries, Inc. (Walker, US). The FDA issued a Cleared decision on March 24, 1983 after a review of 48 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6740 - 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 Devon Industries, Inc. devices

FDA 510(k) Submission Details - K830381

510(k) Number K830381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1983
Decision Date March 24, 1983
Days to Decision 48 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
81d faster than avg
Panel avg: 129d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAZ Device Classification - Class 2, Special Controls

Product Code GAZ Tubing, Noninvasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6740
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 - GAZ Tubing, Noninvasive

All 12
Devices cleared under the same product code (GAZ) and FDA review panel - the closest regulatory comparables to K830381.
SURGICAL CONNECTING TUBES
K883473 · Westmark, Sterile Packing Systems, Inc. (Sps) · Aug 1988
5 - IN - 1 CONNECTOR
K864964 · Medovations, Inc. · Jan 1987
STERILE 5 IN 1 CONNECTORS
K830835 · Abco Dealers, Inc. · Apr 1983
PLEUROFIX THORACENTESIS KIT
K820004 · Burron Medical Products, Inc. · Feb 1982
ARGYLE CONNECT TUBE-CON & NON
K802777 · Sherwood Medical Co. · Dec 1980
LATEX PENROSE TUBING CAT. #20400,414,416
K802761 · American Hospital Supply Corp. · Nov 1980