Cleared Special

K014083 - HAEMONETICS CELL SAVER 5 AUTOLOGOUS BLO...

K014083 is an FDA 510(k) clearance for HAEMONETICS CELL SAVER 5 AUTOLOGOUS BLO..., manufactured by Haemonetics Corp.. The device is a Class 2 Anesthesiology device with product code CAC cleared through the Special 510(k) pathway after a 28-day FDA review.

K014083 · Haemonetics Corp. · Anesthesiology device
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Jan 2002
Decision
28d
Days
Class 2
Risk

K014083 is an FDA 510(k) clearance for the HAEMONETICS CELL SAVER 5 AUTOLOGOUS 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 January 8, 2002 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Haemonetics Corp. devices

FDA 510(k) Submission Details - K014083

510(k) Number K014083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2001
Decision Date January 08, 2002
Days to Decision 28 days
Submission Type Special
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
112d faster than avg
Panel avg: 140d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 K014083.
ACCESS CONCENTRATION SYSTEM, MODEL ACC-100, ACCESS DISPOSABLE SET, MODEL ADS-2000
K022348 · Interpore Cross Intl. · Aug 2002
ACCESS SEQUESTRATION SYSTEM
K012406 · Interpore Cross Intl. · Mar 2002
AUTOVAC ORTHOPEDIC AUTOTRANSFUSION SYSTEM
K014187 · Boehringer Laboratories · Feb 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 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH THE CRIT-LINE HEMATOCRIT SAMPLING SYSTEM OPTION
K991986 · Cobe Cardiovascular, Inc. · Sep 1999
COBE BRAT 2 SYSTEM WITH MODIFIED STANDARD VOLUME PROCESSING SET
K974897 · Cobe Cardiovascular, Inc. · Mar 1998