Cleared Traditional

K841399 - BRONCHOSCOPE SUCTION UNIT

K841399 is an FDA 510(k) clearance for BRONCHOSCOPE SUCTION UNIT, manufactured by Keymed, Inc.. The device is a Class 2 General & Plastic Surgery device with product code BTA cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K841399 · Keymed, Inc. · General & Plastic Surgery device
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Jul 1984
Decision
106d
Days
Class 2
Risk

K841399 is an FDA 510(k) clearance for the BRONCHOSCOPE SUCTION UNIT. Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by Keymed, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 18, 1984 after a review of 106 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 Keymed, Inc. devices

FDA 510(k) Submission Details - K841399

510(k) Number K841399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1984
Decision Date July 18, 1984
Days to Decision 106 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 115d · This submission: 106d
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 106
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K841399.
PORTASPIR II
K851560 · Roseburg SA · Dec 1985
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
EMERGENCY ASPIRATOR
K833785 · Vitalograph , Ltd. · Dec 1983
PSI SURGICAL ASPIRATOR
K832100 · Advanced Biosearch Assn. · Oct 1983
CONNECTING TUBES
K831007 · Medovations, Inc. · May 1983