Cleared Traditional

K932890 - CELL SAVER 5 SYSTEM

K932890 is an FDA 510(k) clearance for CELL SAVER 5 SYSTEM, 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 205-day FDA review.

K932890 · Haemonetics Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1994
Decision
205d
Days
Class 2
Risk

K932890 is an FDA 510(k) clearance for the CELL SAVER 5 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 January 5, 1994 after a review of 205 days - an extended review 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: 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 - K932890

510(k) Number K932890 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1993
Decision Date January 05, 1994
Days to Decision 205 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 140d · This submission: 205d
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 K932890.
AUTOVAC CLOSED WOUND AUTOTRANSFUSION SYSTEM,7920 S
K932093 · Boehringer Laboratories · Jul 1994
PLASMA RECOVERY PROGRAM FOR THE COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM
K933960 · Cobe Cardiovascular, Inc. · Jun 1994
AUTOTRANSFUSION SUCTION RESERVOIR WITH FILTER
K940678 · Baxter Healthcare Corp · Apr 1994
BRAT 2 AUTOLOGUS BLOOD SALVAGE SYSTEM
K933625 · Cobe Cardiovascular, Inc. · Dec 1993
DAVOL CARDIOVASCULAR AUTOTRANSFUSION UNIT
K931552 · Davol, Inc. · Oct 1993
BIOSURGE(TM) SYNCHRONOUS AUTOTRANS PROCEDURE KIT
K931106 · Deknatel, Inc. · Oct 1993