Cleared Traditional

K800135 - CARDIOPLEGIA ADMINISTRATION SYSTEM CAS

K800135 is an FDA 510(k) clearance for CARDIOPLEGIA ADMINISTRATION SYSTEM CAS, manufactured by Bentley Laboratories, Inc.. The device is a Class 2 Cardiovascular device with product code KRJ cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K800135 · Bentley Laboratories, Inc. · Cardiovascular device
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Feb 1980
Decision
11d
Days
Class 2
Risk

K800135 is an FDA 510(k) clearance for the CARDIOPLEGIA ADMINISTRATION SYSTEM CAS. Classified as Filter, Prebypass, Cardiopulmonary Bypass (product code KRJ), Class II - Special Controls.

Submitted by Bentley Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 1, 1980 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4280 - 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 Bentley Laboratories, Inc. devices

FDA 510(k) Submission Details - K800135

510(k) Number K800135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1980
Decision Date February 01, 1980
Days to Decision 11 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
114d faster than avg
Panel avg: 125d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRJ Device Classification - Class 2, Special Controls

Product Code KRJ Filter, Prebypass, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4280
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 - KRJ Filter, Prebypass, Cardiopulmonary Bypass

All 17
Devices cleared under the same product code (KRJ) and FDA review panel - the closest regulatory comparables to K800135.
INTERFACE PRE BYPASS PRIME FILTER #90
K812244 · Medical, Inc. · Aug 1981
PRE-BYPASS FILTER
K810395 · Texas Medical Products, Inc. · Mar 1981
PREBYPASS FILTER CAT.#K-5
K803101 · Delta Medical Industries · Dec 1980
RECIRCULATION FILTER MODEL RF-10
K790361 · Bentley Laboratories, Inc. · Mar 1979
PREBYPASS FILTER
K780485 · Delta Medical Industries · Apr 1978