Cleared Traditional

K883934 - CELL SAVER HAEMOLITE B AUTO. BLOOD RECO...

K883934 is an FDA 510(k) clearance for CELL SAVER HAEMOLITE B AUTO. BLOOD RECO..., manufactured by Haemonetics Corp.. The device is a Class 2 Anesthesiology device with product code CAC cleared through the Traditional 510(k) pathway after a 103-day FDA review.

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

FDA 510(k) Submission Details - K883934

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
Combination Product No
PCCP Authorized No
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.

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 K883934.
AUTOTRANSFUSION DEVICE
K892819 · Impra, Inc. · May 1989
SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM-PROGRAMM
K884564 · Shiley, Inc. · May 1989
PLEUR-EVAC(R) A-7002--ADULT/PEDIATRIC DRAINAGE
K884844 · Deknatel, Inc. · Jan 1989
PLEUR-EVAC(R)-A-7020-INFANT CHEST DRAIN SYSTEM
K883082 · Deknatel, Inc. · Oct 1988
CBC/CONSTAVAC BLOOD CONSERVATION SYSTEM
K881350 · Stryker Corp. · Sep 1988
ATS BLOOD RECOVERY BAG
K883663 · Atrium Medical Corp. · Sep 1988