Cleared Traditional

K011725 - OLYMPUS SUCTION PUMP

K011725 is an FDA 510(k) clearance for OLYMPUS SUCTION PUMP, manufactured by Keymed (Medical & Industrial Equipment), Ltd.. The device is a Class 2 General & Plastic Surgery device with product code JCX cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K011725 · Keymed (Medical & Industrial Equipment), Ltd. · General & Plastic Surgery device
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Aug 2001
Decision
88d
Days
Class 2
Risk

K011725 is an FDA 510(k) clearance for the OLYMPUS SUCTION PUMP, MODEL KV-5. Classified as Apparatus, Suction, Ward Use, Portable, Ac-powered (product code JCX), Class II - Special Controls.

Submitted by Keymed (Medical & Industrial Equipment), Ltd. (Southend-On-Sea, Essex, GB). The FDA issued a Cleared decision on August 31, 2001 after a review of 88 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. 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.

View all Keymed (Medical & Industrial Equipment), Ltd. devices

FDA 510(k) Submission Details - K011725

510(k) Number K011725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2001
Decision Date August 31, 2001
Days to Decision 88 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 115d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JCX Device Classification - Class 2, Special Controls

Product Code JCX Apparatus, Suction, Ward Use, Portable, Ac-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 - JCX Apparatus, Suction, Ward Use, Portable, Ac-powered

All 23
Devices cleared under the same product code (JCX) and FDA review panel - the closest regulatory comparables to K011725.
VACPLUS SUCTION UNIT
K103535 · Apex Medical Corp. · Feb 2011
ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM
K080845 · Cardinalhealth · Apr 2008
BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM
K060277 · Boehringer Laboratories · Mar 2006
VACPLUS
K945062 · Kinetic Concepts, Inc. · Mar 1995
ANNELID
K940886 · Kinetic Concepts, Inc. · Nov 1994
SUCTION TUBES: HOUSE, BARON
K930030 · Thomasville Medical Assoc. · Feb 1994