Cleared Traditional

K893402 - COMPACT 2052(TM) DUAL COLLECTION BLOOD ...

K893402 is an FDA 510(k) clearance for COMPACT 2052(TM) DUAL COLLECTION BLOOD ..., 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 53-day FDA review.

K893402 · Atrium Medical Corp. · Anesthesiology device
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Jun 1989
Decision
53d
Days
Class 2
Risk

K893402 is an FDA 510(k) clearance for the COMPACT 2052(TM) DUAL COLLECTION BLOOD RECOVERY. 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 June 23, 1989 after a review of 53 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 - K893402

510(k) Number K893402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1989
Decision Date June 23, 1989
Days to Decision 53 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
87d faster than avg
Panel avg: 140d · This submission: 53d
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 K893402.
ORTHOPEDIC WOUND DRAINAGE SET WITH TROCAR
K893394 · Haemonetics Corp. · Oct 1989
DIDECO-SHILEY UNIVERSAL Y
K894294 · Shiley, Inc. · Aug 1989
PHARMASEAL MEDI-VAC STERILE POST-OP AUTOTRANS. SYS
K893578 · Baxter Healthcare Corp · Aug 1989
INLINE AUTOTRANSFUSION SYSTEM
K890171 · Conmedcorp · Jun 1989
HARVESTING TUBE
K892857 · Conmedcorp · Jun 1989
AUTOTRANSFUSION DEVICE
K892819 · Impra, Inc. · May 1989