Cleared Traditional

K993668 - LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20

K993668 is an FDA 510(k) clearance for LAERDAL SUCTION UNIT, manufactured by Laerdal Medical A/S. The device is a Class 2 General & Plastic Surgery device with product code BTA cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K993668 · Laerdal Medical A/S · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 1999
Decision
49d
Days
Class 2
Risk

K993668 is an FDA 510(k) clearance for the LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20. Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by Laerdal Medical A/S (Stavanger, NO). The FDA issued a Cleared decision on December 20, 1999 after a review of 49 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.

FDA 510(k) Submission Details - K993668

510(k) Number K993668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1999
Decision Date December 20, 1999
Days to Decision 49 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 115d · This submission: 49d
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 118
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K993668.
MEDIPORT 2000 MOBILE
K013585 · Servox Medizintechnik GmbH · Jan 2002
DURQ/ QUALIDURA
K013116 · Ever-Safety Technical Service · Jan 2002
ARDO SUCTION PUMP MASTER, MODEL 30.00.XX
K011601 · Ardo Medical AG · Jun 2001
SORING GMBH, SONOCA 300
K992026 · Soring GmbH Medizintechnik · Sep 1999
XPS TISSUE ASPIRATION SYSTEM, XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM
K984363 · Xomed, Inc. · Feb 1999
MEDCO ASPIRATOR IV
K982371 · Medco Mfg. · Feb 1999