Cleared Traditional

K935977 - SARNS AIR DETECTION SYSTEM

K935977 is an FDA 510(k) clearance for SARNS AIR DETECTION SYSTEM, manufactured by 3M Health Care, Sarns. The device is a Class 2 Cardiovascular device with product code KRL cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K935977 · 3M Health Care, Sarns · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
53d
Days
Class 2
Risk

K935977 is an FDA 510(k) clearance for the SARNS AIR DETECTION SYSTEM. Classified as Detector, Bubble, Cardiopulmonary Bypass (product code KRL), Class II - Special Controls.

Submitted by 3M Health Care, Sarns (Ann Arbor, US). The FDA issued a Cleared decision on February 4, 1994 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4205 - 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 3M Health Care, Sarns devices

FDA 510(k) Submission Details - K935977

510(k) Number K935977 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1993
Decision Date February 04, 1994
Days to Decision 53 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 125d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRL Device Classification - Class 2, Special Controls

Product Code KRL Detector, Bubble, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4205
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 - KRL Detector, Bubble, Cardiopulmonary Bypass

All 13
Devices cleared under the same product code (KRL) and FDA review panel - the closest regulatory comparables to K935977.
AUTOMATIC TUBING CLAMP SYSTEM (ATC)
K961364 · Rocky Mountain Research, Inc. · Oct 1996
ELS AUTOMATIC TUBING CLAMP SYSTEM
K961598 · Rocky Mountain Research, Inc. · Oct 1996
SARNS ULTRASONIC AIR SENSOR
K940651 · 3M Health Care, Sarns · May 1994
STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE
K925661 · Sorin Biomedica, Fiat, USA, Inc. · May 1993
STOCKERT 1/4 BUBBLE SENSOR
K925541 · Sorin Biomedica, Fiat, USA, Inc. · Feb 1993
CAPIOX(R) BUBBLE TRAP
K911632 · Terumo Medical Corp. · Jul 1991