Cleared Traditional

K823273 - BOS-2S

K823273 is the FDA 510(k) clearance for BOS-2S by Bentley Laboratories, Inc.. It is a Class 2 Cardiovascular device (product code DTZ) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K823273 · Bentley Laboratories, Inc. · Cardiovascular device
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Jan 1983
Decision
64d
Days
Class 2
Risk

K823273 is an FDA 510(k) clearance for the BOS-2S, SPIRAFLO BUBBLE INFANT OXYGEN.. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Bentley Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 5, 1983 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4350 - 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

Submission Details

510(k) Number K823273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1982
Decision Date January 05, 1983
Days to Decision 64 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
61d faster than avg
Panel avg: 125d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTZ Oxygenator, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4350
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 - DTZ Oxygenator, Cardiopulmonary Bypass

All 191
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K823273.
HI FLEX D-700 MODULAR BUBBLE OXYGENA-
K830639 · Electromedics, Inc. · May 1983
WILLIAM HARVEY H-1700 ADULT BLOOD OXYG-
K831122 · C.R. Bard, Inc. · May 1983
DOSIMETRIC RELEASE OF RADIATION DEV
K830327 · American Bentley · Mar 1983
OXYGENATORS #BOS-10, 105, 5S
K823456 · Bentley Laboratories, Inc. · Dec 1982
OXYGENATOR 10
K823343 · Gambro, Inc. · Dec 1982
CAPIOX II
K823125 · Terumo Medical Corp. · Nov 1982