Cleared Traditional

K831260 - SCI MED TEMPERATURE MONITORING ADAPTOR

K831260 is the FDA 510(k) clearance for SCI MED TEMPERATURE MONITORING ADAPTOR by Scimed Life Systems, Inc.. It is a Class 2 Cardiovascular device (product code DTL) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K831260 · Scimed Life Systems, Inc. · Cardiovascular device
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Jun 1983
Decision
46d
Days
Class 2
Risk

K831260 is an FDA 510(k) clearance for the SCI MED TEMPERATURE MONITORING ADAPTOR. Classified as Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL), Class II - Special Controls.

Submitted by Scimed Life Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 3, 1983 after a review of 46 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 Scimed Life Systems, Inc. devices

Submission Details

510(k) Number K831260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1983
Decision Date June 03, 1983
Days to Decision 46 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
79d faster than avg
Panel avg: 125d · This submission: 46d
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 65
Devices cleared under the same product code (DTL) and FDA review panel - the closest regulatory comparables to K831260.
MALE-MALE LUER LOCK CONNECTOR W/ROTA
K840797 · American Pharmaseal Div. Ahsc · Apr 1984
ARTERIAL FILTER PURGE LINE W/CHECK VALV
K840603 · Shiley, Inc. · Apr 1984
TUBING CONNECTORS EC-2XXX SERIES
K833322 · Gish Biomedical, Inc. · Dec 1983
SCI MED TUBING CONNECTORS
K831261 · Scimed Life Systems, Inc. · Jun 1983
NORTON MANIFOLD
K820864 · Norton Performance Plastics Corp. · Apr 1982
WM. HARVEY OVERPRESSURE SAFETY VALVE
K820297 · C.R. Bard, Inc. · Mar 1982