Cleared Traditional

K840803 - GRAMS ASPIRATOR S-300

K840803 is an FDA 510(k) clearance for GRAMS ASPIRATOR S-300, manufactured by Grams Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code BTA cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K840803 · Grams Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1984
Decision
87d
Days
Class 2
Risk

K840803 is an FDA 510(k) clearance for the GRAMS ASPIRATOR S-300. Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by Grams Medical, Inc. (Walker, US). The FDA issued a Cleared decision on May 21, 1984 after a review of 87 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 Grams Medical, Inc. devices

FDA 510(k) Submission Details - K840803

510(k) Number K840803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1984
Decision Date May 21, 1984
Days to Decision 87 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 115d · This submission: 87d
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 111
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K840803.
STORZ ASPIRATION MACHINE SAM 5000
K843644 · Storz Instrument Co. · Nov 1984
JACOBS HIGH VACUUM SUCTION UNIT 05-2570
K843693 · J. Sklar Mfg. Co., Inc. · Oct 1984
BRONCHOSCOPE SUCTION UNIT
K841399 · Keymed, Inc. · Jul 1984
EMERGENCY ASPIRATOR
K833785 · Vitalograph , Ltd. · Dec 1983
PSI SURGICAL ASPIRATOR
K832100 · Advanced Biosearch Assn. · Oct 1983
CONNECTING TUBES
K831007 · Medovations, Inc. · May 1983