Cleared Traditional

K920628 - QUINEVAC EVACUATOR/ASPIRATOR

K920628 is an FDA 510(k) clearance for QUINEVAC EVACUATOR/ASPIRATOR, manufactured by Recto Molded Products, Inc.. The device is a Class 2 General & Plastic Surgery device with product code BTA cleared through the Traditional 510(k) pathway after a 405-day FDA review.

K920628 · Recto Molded Products, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1993
Decision
405d
Days
Class 2
Risk

K920628 is an FDA 510(k) clearance for the QUINEVAC EVACUATOR/ASPIRATOR. Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by Recto Molded Products, Inc. (Washington, US). The FDA issued a Cleared decision on March 23, 1993 after a review of 405 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 Recto Molded Products, Inc. devices

FDA 510(k) Submission Details - K920628

510(k) Number K920628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1992
Decision Date March 23, 1993
Days to Decision 405 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
290d slower than avg
Panel avg: 115d · This submission: 405d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 108
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K920628.
LIFE VAC
K940934 · Life Support Products, Inc. · May 1994
BATTERY PACK #1005NC
K931348 · Portable Power Systems, Inc. · Feb 1994
PM PUMP ASPIRATOR
K932494 · Precision Medical, Inc. · Oct 1993
INTELIJET SUCTION SUPPLY
K922176 · Smith & Nephew Dyonics, Inc. · Nov 1992
AUTOVAC
K921107 · Life Support Products, Inc. · Sep 1992
VACPAC PORTABLE ASPIRATION SYSTEM
K910271 · Jedmed Instrument Co. · Mar 1991