Cleared Traditional

K041154 - S-SCORT...JR QUICKDRAW, MODEL 2400

K041154 is an FDA 510(k) clearance for S-SCORT...JR QUICKDRAW, manufactured by Sscor. The device is a Class 2 General & Plastic Surgery device with product code BTA cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K041154 · Sscor · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
15d
Days
Class 2
Risk

K041154 is an FDA 510(k) clearance for the S-SCORT...JR QUICKDRAW, MODEL 2400. Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by Sscor (Sun Valley, US). The FDA issued a Cleared decision on May 18, 2004 after a review of 15 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.

View all Sscor devices

FDA 510(k) Submission Details - K041154

510(k) Number K041154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2004
Decision Date May 18, 2004
Days to Decision 15 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 115d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 86
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K041154.
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
XPS TISSUE ASPIRATION SYSTEM, XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM
K984363 · Xomed, Inc. · Feb 1999