Cleared Traditional

LARGE LUMEN Y ADAPTER W/ROTATING DEVICE (K880831) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K880831 · Interventional Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1988
Decision
70d
Days
Class 2
Risk

K880831 is an FDA 510(k) clearance for the LARGE LUMEN Y ADAPTER W/ROTATING DEVICE. Classified as Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL), Class II - Special Controls.

Submitted by Interventional Medical, Inc. (Danvers, US). The FDA issued a Cleared decision on May 10, 1988 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4290 - 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.

View all Interventional Medical, Inc. devices

Submission Details

510(k) Number K880831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1988
Decision Date May 10, 1988
Days to Decision 70 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 125d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4290
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

All 27
Devices cleared under the same product code (DTL) and FDA review panel - the closest regulatory comparables to K880831.
MERIT MANIFOLD
K913161 · Merit Medical Systems, Inc. · Oct 1991
SARNS PRESSURE ADJUSTABLE SAFETY SYSTEM
K893683 · 3M Company · Aug 1989
USCI TANDEM ADAPTER
K884200 · C.R. Bard, Inc. · Dec 1988
DIDECO-SHILEY PREASSEMBLED SURGICAL WASH SET
K872161 · Shiley, Inc. · Aug 1987
LUER LOCK SKIRT
K862451 · Hewlett-Packard Co. · Oct 1986
CORDIS ANGIOPLASTY HEMOSTASIS DEVICES
K863177 · Cordis Corp. · Oct 1986