Cleared Traditional

K930852 - OLYMPUS SUCTION PUMP MODEL KV-4

K930852 is an FDA 510(k) clearance for OLYMPUS SUCTION PUMP MODEL KV-4, 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 406-day FDA review.

K930852 · Keymed (Medical & Industrial Equipment), Ltd. · General & Plastic Surgery device
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Mar 1994
Decision
406d
Days
Class 2
Risk

K930852 is an FDA 510(k) clearance for the OLYMPUS SUCTION PUMP MODEL KV-4. Classified as Apparatus, Suction, Ward Use, Portable, Ac-powered (product code JCX), Class II - Special Controls.

Submitted by Keymed (Medical & Industrial Equipment), Ltd. (Essex, GB). The FDA issued a Cleared decision on March 31, 1994 after a review of 406 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

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

FDA 510(k) Submission Details - K930852

510(k) Number K930852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1993
Decision Date March 31, 1994
Days to Decision 406 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
291d slower than avg
Panel avg: 115d · This submission: 406d
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 K930852.
BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM
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VACPLUS
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ANNELID
K940886 · Kinetic Concepts, Inc. · Nov 1994
SUCTION TUBES: HOUSE, BARON
K930030 · Thomasville Medical Assoc. · Feb 1994
COOK ASPIRATION UNIT
K930900 · Cook Ob/Gyn · Jul 1993
STERILE VIEW(TM) HI EFFIC HELMET/BACK PK SUP/EXHAU
K914694 · Depuy, Inc. · Jan 1992