Cleared Traditional

K041405 - ASPIRATION PUMP, MODEL IMD-020

K041405 is an FDA 510(k) clearance for ASPIRATION PUMP, manufactured by Industrial & Medical Design, Inc.. The device is a Class 2 General & Plastic Surgery device with product code BTA cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K041405 · Industrial & Medical Design, Inc. · General & Plastic Surgery device
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Sep 2004
Decision
99d
Days
Class 2
Risk

K041405 is an FDA 510(k) clearance for the ASPIRATION PUMP, MODEL IMD-020. Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by Industrial & Medical Design, Inc. (Monterey Park, US). The FDA issued a Cleared decision on September 2, 2004 after a review of 99 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 Industrial & Medical Design, Inc. devices

FDA 510(k) Submission Details - K041405

510(k) Number K041405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2004
Decision Date September 02, 2004
Days to Decision 99 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 115d · This submission: 99d
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 93
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K041405.
SMARTSUCTION HARMONY DEVICE
K052626 · Haemonetics Corp. · Oct 2005
PENUMBRA ASPIRATION PUMP, MODEL 115V
K051758 · Penumbra, Inc. · Aug 2005
MEDELA DOMINANT 35 C/I SECRETION AND SURGICAL ASPIRATOR
K043544 · Medela AG · Jan 2005
MEDELA CLARIO HOME CARE PUMP
K033179 · Medela AG · Oct 2003
MEDELA BASIC 30 AND DOMINANT 50 SUCTION PUMPS, MODELS 037, 057
K021368 · Medela AG · May 2002
LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20
K993668 · Laerdal Medical A/S · Dec 1999