Cleared Traditional

K022489 - SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SYSTEM, MODELS ABT4510, ABT4512 & ABT4514

K022489 is an FDA 510(k) clearance for SUMMIT MEDICAL LTD CELLTRANS POSTOPERAT..., manufactured by Summit Medical , Ltd.. The device is a Class 2 Anesthesiology device with product code CAC cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K022489 · Summit Medical , Ltd. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
72d
Days
Class 2
Risk

K022489 is an FDA 510(k) clearance for the SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SYSTEM, MODELS ABT.... Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Summit Medical , Ltd. (Stevenage Hertfordshire, GB). The FDA issued a Cleared decision on October 9, 2002 after a review of 72 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K022489

510(k) Number K022489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2002
Decision Date October 09, 2002
Days to Decision 72 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
68d faster than avg
Panel avg: 140d · This submission: 72d
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 194
Devices cleared under the same product code (CAC) and FDA review panel - the closest regulatory comparables to K022489.
S-1150 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM
K031554 · Genzyme Biosurgery · Jul 2003
PALL DONER PRE-EVACUATED POST-OPERATIVE AUTOLOGOUS BLOOD REINFUSION SYSTEM
K022167 · Pall Corp. · Mar 2003
SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SET, MODELS AB400-10, AB400-12, AB400-14
K024097 · Summit Medical , Ltd. · Feb 2003
DIDECO ELECTA
K020647 · Dideco S.P.A. · Sep 2002
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
K022489 · SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SYSTEM, MODELS ABT4510, ABT4512 & ABT4514
Download PDF FDA Summary Summit Medical , Ltd.