Cleared Special

K062610 - CARE-E-VAC 3

K062610 is an FDA 510(k) clearance for CARE-E-VAC 3, manufactured by Ohio Medical Corporation. The device is a Class 2 General & Plastic Surgery device with product code BTA cleared through the Special 510(k) pathway after a 23-day FDA review.

K062610 · Ohio Medical Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
23d
Days
Class 2
Risk

K062610 is an FDA 510(k) clearance for the CARE-E-VAC 3. Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by Ohio Medical Corporation (Gurnee, US). The FDA issued a Cleared decision on September 28, 2006 after a review of 23 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4780 - the FDA general and plastic surgery 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 Ohio Medical Corporation devices

FDA 510(k) Submission Details - K062610

510(k) Number K062610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2006
Decision Date September 28, 2006
Days to Decision 23 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 115d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

BTA Device Classification - Class 2, Special Controls

Product Code BTA Pump, Portable, Aspiration (manual Or Powered)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4780
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - BTA Pump, Portable, Aspiration (manual Or Powered)

All 92
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K062610.
GENADYNE A4 POWERED SUCTION PUMP
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MEDELA THOPAZ, MODEL 200 0288
K080212 · Medela AG · Jul 2008
SMARTSUCTION SOLO DEVICE
K062801 · Haemonetics Corp. · Oct 2006
MEDELA VARIO 8/18/CI SECRETION & SURGICAL ASPIRATOR
K061205 · Medela AG · Jun 2006
PIONEER U601 SERIES ASPIRATOR
K052650 · Merits Health Products Co., Ltd. · Nov 2005
SMARTSUCTION HARMONY DEVICE
K052626 · Haemonetics Corp. · Oct 2005