Cleared Traditional

K852124 - HEMATOCRIT-SATURATION MONITOR HSM-100

K852124 is an FDA 510(k) clearance for HEMATOCRIT-SATURATION MONITOR HSM-100, manufactured by American Bentley. The device is a Class 2 Cardiovascular device with product code DRY cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K852124 · American Bentley · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1985
Decision
124d
Days
Class 2
Risk

K852124 is an FDA 510(k) clearance for the HEMATOCRIT-SATURATION MONITOR HSM-100. Classified as Monitor, Blood-gas, On-line, Cardiopulmonary Bypass (product code DRY), Class II - Special Controls.

Submitted by American Bentley (Irvine, US). The FDA issued a Cleared decision on September 16, 1985 after a review of 124 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4330 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all American Bentley devices

FDA 510(k) Submission Details - K852124

510(k) Number K852124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1985
Decision Date September 16, 1985
Days to Decision 124 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
1d faster than avg
Panel avg: 125d · This submission: 124d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRY Device Classification - Class 2, Special Controls

Product Code DRY Monitor, Blood-gas, On-line, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4330
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 - DRY Monitor, Blood-gas, On-line, Cardiopulmonary Bypass

All 25
Devices cleared under the same product code (DRY) and FDA review panel - the closest regulatory comparables to K852124.
APPLICARD (EKG)
K900459 · Medi-Globe Corp. · Jul 1990
STOCKERT-SHILEY BUBBLE MONITOR 23-23-01
K881006 · Shiley, Inc. · May 1988
STAT-SAT
K874839 · Gish Biomedical, Inc. · May 1988
COBE SATURATION CELL
K843709 · Cobe Laboratories, Inc. · Oct 1984
OXYGEN CONSUMPTION MONITOR #OCM-0100
K823359 · Bentley Laboratories, Inc. · Jan 1983
IN-LINE OXYGEN MONITORING SYSTEM
K821159 · G.D. Searle and Co. · May 1982