Cleared Traditional

K881796 - UMI DISPOSABLE BUTTERFLY STYLE PUNCTURE NEEDLE

K881796 is an FDA 510(k) clearance for UMI DISPOSABLE BUTTERFLY STYLE PUNCTURE..., manufactured by Universal Medical Instrument Corp.. The device is a Class 1 Cardiovascular device with product code DWS cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K881796 · Universal Medical Instrument Corp. · Cardiovascular device
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Jul 1988
Decision
90d
Days
Class 1
Risk

K881796 is an FDA 510(k) clearance for the UMI DISPOSABLE BUTTERFLY STYLE PUNCTURE NEEDLE. Classified as Instruments, Surgical, Cardiovascular (product code DWS), Class I - General Controls.

Submitted by Universal Medical Instrument Corp. (Ballston Spa, US). The FDA issued a Cleared decision on July 26, 1988 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K881796

510(k) Number K881796 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1988
Decision Date July 26, 1988
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
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 K881796.
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K882479 · Medtronic Blood Systems, Inc. · Jul 1988
PTI HEART-LIFT(TM) CARDIAC SUPPORT SLING (STERILE)
K881717 · Buckman Co., Inc. · Jul 1988
CARDICAD(TM)
K881392 · Medical/Surgical Specialties, Ltd. · May 1988
K881796 · UMI DISPOSABLE BUTTERFLY STYLE PUNCTURE NEEDLE
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