Cleared Traditional

K821321 - SNYDER DEBRIBEMENT SYSTEM LDP-1

K821321 is an FDA 510(k) clearance for SNYDER DEBRIBEMENT SYSTEM LDP-1, manufactured by Snyder Laboratories, Inc.. The device is a Class 2 General & Plastic Surgery device with product code BTA cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K821321 · Snyder Laboratories, Inc. · General & Plastic Surgery device
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Aug 1982
Decision
94d
Days
Class 2
Risk

K821321 is an FDA 510(k) clearance for the SNYDER DEBRIBEMENT SYSTEM LDP-1. Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by Snyder Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 6, 1982 after a review of 94 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Snyder Laboratories, Inc. devices

FDA 510(k) Submission Details - K821321

510(k) Number K821321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1982
Decision Date August 06, 1982
Days to Decision 94 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 115d · This submission: 94d
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 111
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K821321.
EMERGENCY ASPIRATOR
K833785 · Vitalograph , Ltd. · Dec 1983
PSI SURGICAL ASPIRATOR
K832100 · Advanced Biosearch Assn. · Oct 1983
CONNECTING TUBES
K831007 · Medovations, Inc. · May 1983
KEYMED KEY VAC SUCTION PUMP
K820739 · Keymed, Inc. · May 1982
IMPACT, MODELS 306/307
K820338 · Impact Instrumentation, Inc. · Mar 1982
GOMCO SUCTION PUMP CABINET CHANGE
K810490 · Allied Healthcare Products, Inc. · Mar 1981