Cleared Traditional

K963775 - MODEL 8800 ASPIRATOR

K963775 is an FDA 510(k) clearance for MODEL 8800 ASPIRATOR, manufactured by Medical Specifics, Inc.. The device is a Class 2 General & Plastic Surgery device with product code BTA cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K963775 · Medical Specifics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
188d
Days
Class 2
Risk

K963775 is an FDA 510(k) clearance for the MODEL 8800 ASPIRATOR. Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by Medical Specifics, Inc. (Carrollton, US). The FDA issued a Cleared decision on March 26, 1997 after a review of 188 days - an extended review 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: 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 Medical Specifics, Inc. devices

FDA 510(k) Submission Details - K963775

510(k) Number K963775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1996
Decision Date March 26, 1997
Days to Decision 188 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 115d · This submission: 188d
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 99
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K963775.
PSI-TEC ASPIRATOR
K980392 · Byron Medical · Mar 1998
MICROAIRE POWER ASPIRATION DEVICE PAD SYSTEM
K973268 · Microaire Surgical Instruments, Inc. · Nov 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER STR5
K971107 · Alexander Mfg. Co. · Jun 1997
S-SCORT (2500)
K964997 · Sscor · Mar 1997
CPI, MAXI-VAC(6480),THOMAS INDUSTRIES, MEDI-PUMP(1240/1242/1243)
K965059 · Thomas Industries · Mar 1997
GI SUPPLY PARACENTESIS PUMP
K970186 · Gi Supply · Feb 1997