Cleared Traditional

K897126 - ATRIUM 2050 CHEST DRAIN BLOOD RECOVERY ...

K897126 is an FDA 510(k) clearance for ATRIUM 2050 CHEST DRAIN BLOOD RECOVERY ..., manufactured by Atrium Medical Corp.. The device is a Class 2 Anesthesiology device with product code CAC cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K897126 · Atrium Medical Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1990
Decision
77d
Days
Class 2
Risk

K897126 is an FDA 510(k) clearance for the ATRIUM 2050 CHEST DRAIN BLOOD RECOVERY SYSTEM. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Atrium Medical Corp. (Hollis, US). The FDA issued a Cleared decision on March 13, 1990 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5830 - the FDA anesthesiology and respiratory device 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 Atrium Medical Corp. devices

FDA 510(k) Submission Details - K897126

510(k) Number K897126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1989
Decision Date March 13, 1990
Days to Decision 77 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 140d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAC Device Classification - Class 2, Special Controls

Product Code CAC Apparatus, Autotransfusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5830
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - CAC Apparatus, Autotransfusion

All 137
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K897126.
AUTOVAC(R) AUTOTRANSFUSION SYSTEM, 7900 SERIES
K901138 · Boehringer Laboratories · Jun 1990
AP900/PRP MODULE AND ACCESSORIES, MODIFICATION
K893218 · Electromedics, Inc. · Jun 1990
AUTOTRANSFUSION RESERVIOR MODEL 7900 MODIFICATION
K895297 · Boehringer Laboratories · Mar 1990
ATRIUM 2052 CHEST DRAIN, DUAL COLLECTION BLOOD
K897127 · Atrium Medical Corp. · Mar 1990
BLOOD RECOVERY/AUTOTRANSFUSION RESERVOIR ATR-2900
K892443 · Gish Biomedical, Inc. · Nov 1989
MODIFIED SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM
K894668 · Shiley, Inc. · Oct 1989