Cleared Traditional

K991986 - COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SY...

K991986 is an FDA 510(k) clearance for COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SY..., manufactured by Cobe Cardiovascular, Inc.. The device is a Class 2 Hematology device with product code CAC cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K991986 · Cobe Cardiovascular, Inc. · Hematology device
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Sep 1999
Decision
87d
Days
Class 2
Risk

K991986 is an FDA 510(k) clearance for the COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH THE CRIT-LINE HEMATOCRIT SAM.... Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Cobe Cardiovascular, Inc. (Arvada, US). The FDA issued a Cleared decision on September 9, 1999 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 868.5830 - the FDA hematology 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 Cobe Cardiovascular, Inc. devices

FDA 510(k) Submission Details - K991986

510(k) Number K991986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1999
Decision Date September 09, 1999
Days to Decision 87 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 113d · This submission: 87d
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 Hematology 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 K991986.
AUTOVAC ORTHOPEDIC AUTOTRANSFUSION SYSTEM
K014187 · Boehringer Laboratories · Feb 2002
HAEMONETICS CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM
K014083 · Haemonetics Corp. · Jan 2002
HAEMONETICS LN 193 DISPOSABLE SET, FOR USE WITH THE HAEMONETICS CELLSEVER HAEMOLITE 2 FAMILY OF AUTOLOGOUS BLOOD RECOVER
K993581 · Haemonetics Corp. · Nov 1999
COBE BRAT 2 SYSTEM WITH MODIFIED STANDARD VOLUME PROCESSING SET
K974897 · Cobe Cardiovascular, Inc. · Mar 1998
STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII)
K970714 · Stryker Instruments · Dec 1997
ARGYLE AQUA-SEAL ALL PURPOSE AUTOTRANSFUSION CHEST DRAINAGE UNIT AND OPTIONAL ARGYLE AQUA-SEAL EVACUATING AUTOTRANSFUSIO
K970857 · Davis & Geck, Inc. · Nov 1997