Cleared Traditional

K945929 - S-SCORT(R)DUET MODEL 2014 PORTABLE SUCTION PUMP

K945929 is an FDA 510(k) clearance for S-SCORTDUET MODEL 2014 PORTABLE SUCTION..., 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 17-day FDA review.

K945929 · Sscor · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 1994
Decision
17d
Days
Class 2
Risk

K945929 is an FDA 510(k) clearance for the S-SCORT(R)DUET MODEL 2014 PORTABLE SUCTION PUMP. 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 December 22, 1994 after a review of 17 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 - K945929

510(k) Number K945929 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1994
Decision Date December 22, 1994
Days to Decision 17 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
98d faster than avg
Panel avg: 115d · This submission: 17d
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 130
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K945929.
605 VACU-MAX
K941961 · Medical Industries America, Inc. · Mar 1995
MEDI-PUMP
K944399 · Thomas Industries · Jan 1995
ELECTRIC VACUM PUMP
K941096 · Impact Instrumentation, Inc. · Jan 1995
COOK ASPIRATION/IRRIGATION UNIT
K944818 · Cook Urological, Inc. · Nov 1994
FREEDOM ASPIRATOR, MODEL 6000
K944116 · Stackhouse, Inc. · Sep 1994
HAND-HELD IRRIGATION PUMP
K933757 · Ximed Medical Systems · Aug 1994
K945929 · S-SCORT(R)DUET MODEL 2014 PORTABLE SUCTION PUMP
Download PDF FDA Summary Sscor