Cleared Special

K993581 - HAEMONETICS LN 193 DISPOSABLE SET

K993581 is an FDA 510(k) clearance for HAEMONETICS LN 193 DISPOSABLE SET, 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 27-day FDA review.

K993581 · Haemonetics Corp. · Anesthesiology device
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Nov 1999
Decision
27d
Days
Class 2
Risk

K993581 is an FDA 510(k) clearance for the HAEMONETICS LN 193 DISPOSABLE SET, FOR USE WITH THE HAEMONETICS CELLSEVER HAE.... Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Haemonetics Corp. (Braintree, US). The FDA issued a Cleared decision on November 18, 1999 after a review of 27 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 - K993581

510(k) Number K993581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1999
Decision Date November 18, 1999
Days to Decision 27 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
113d faster than avg
Panel avg: 140d · This submission: 27d
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 K993581.
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K991986 · Cobe Cardiovascular, Inc. · Sep 1999
COBE BRAT 2 SYSTEM WITH MODIFIED STANDARD VOLUME PROCESSING SET
K974897 · Cobe Cardiovascular, Inc. · Mar 1998
STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII)
K970714 · Stryker Instruments · Dec 1997