Cleared Traditional

CELL SAVER HAEMOLITE B AUTO. BLOOD RECOVERY SYSTEM (K883934) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K883934 · Haemonetics Corp. · Anesthesiology device
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Dec 1988
Decision
103d
Days
Class 2
Risk

K883934 is an FDA 510(k) clearance for the CELL SAVER HAEMOLITE B AUTO. BLOOD RECOVERY SYSTEM. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Haemonetics Corp. (Braintree, US). The FDA issued a Cleared decision on December 27, 1988 after a review of 103 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Haemonetics Corp. devices

Submission Details

510(k) Number K883934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1988
Decision Date December 27, 1988
Days to Decision 103 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 140d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 38
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K883934.
DIDECO-SHILEY UNIVERSAL Y
K894294 · Shiley, Inc. · Aug 1989
PHARMASEAL MEDI-VAC STERILE POST-OP AUTOTRANS. SYS
K893578 · Baxter Healthcare Corp · Aug 1989
SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM-PROGRAMM
K884564 · Shiley, Inc. · May 1989
CBC/CONSTAVAC BLOOD CONSERVATION SYSTEM
K881350 · Stryker Corp. · Sep 1988
ARGYLE AUTOTRANSFUSION BAG
K882757 · Sherwood Medical Co. · Sep 1988
DIDECO-SHILEY FLUID COLLECTION BAG
K881692 · Shiley, Inc. · Jul 1988