Cleared Traditional

POLYURETHANE PROD. FOR I.V. NEEDLES (K771125) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K771125 · Devon Industries, Inc. · General & Plastic Surgery device
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Aug 1977
Decision
41d
Days
Class 1
Risk

K771125 is an FDA 510(k) clearance for the POLYURETHANE PROD. FOR I.V. NEEDLES. Classified as Strip, Adhesive, Closure, Skin (product code FPX), Class I - General Controls.

Submitted by Devon Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 2, 1977 after a review of 41 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5240 - 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 Devon Industries, Inc. devices

Submission Details

510(k) Number K771125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1977
Decision Date August 02, 1977
Days to Decision 41 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
74d faster than avg
Panel avg: 115d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FPX Strip, Adhesive, Closure, Skin
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5240
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 - FPX Strip, Adhesive, Closure, Skin

All 9
Devices cleared under the same product code (FPX) and FDA review panel - the closest regulatory comparables to K771125.
PAPER TAPE, HYPO ALLERGENIC
K781952 · Johnson & Johnson Professionals, Inc. · Dec 1978
SUTURELESS SKIN CLOSURE
K780565 · Abbott Laboratories · Jul 1978
CLOTH ADHESIVE TAPE
K772020 · Johnson & Johnson Professionals, Inc. · Nov 1977
BAND-AID BRAND ADHES. BAND.-SHEER STRIPS
K770533 · Johnson & Johnson Professionals, Inc. · Jun 1977
BAND-AID BRAND OF ADHESIVE BANDAGES
K770081 · Johnson & Johnson Professionals, Inc. · Mar 1977
BANDAGE, PLASTIC & SHEER
K770339 · Johnson & Johnson Professionals, Inc. · Feb 1977