Cleared Traditional

K841318 - A.S.A.P.

K841318 is an FDA 510(k) clearance for A.S.A.P., manufactured by Trimedyne, Inc.. The device is a Class 2 General Hospital device with product code LDR cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K841318 · Trimedyne, Inc. · General Hospital
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Jul 1984
Decision
107d
Days
Class 2
Risk

K841318 is an FDA 510(k) clearance for the A.S.A.P.. Classified as Controller, Infusion, Intravascular, Electronic (product code LDR), Class II - Special Controls.

Submitted by Trimedyne, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 18, 1984 after a review of 107 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital 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 Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Trimedyne, Inc. devices

FDA 510(k) Submission Details - K841318

510(k) Number K841318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1984
Decision Date July 18, 1984
Days to Decision 107 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 129d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LDR Device Classification - Class 2, Special Controls

Product Code LDR Controller, Infusion, Intravascular, Electronic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 Hospital devices follow this clearance model.

Regulatory Peers - LDR Controller, Infusion, Intravascular, Electronic

All 30
Devices cleared under the same product code (LDR) and FDA review panel - the closest regulatory comparables to K841318.
FLO-GARD 4000 VOLUMETRIC INFUSION CONTROLLER
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IVAC 280 VOLUMETRIC INFUSION CONTROLLER
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ABBOTT LIFECARE 1050 CONTROLLER
K842080 · Abbott Laboratories · Jul 1984
INTRAVENOUS INFUSION CONTROLLER
K834106 · Cutter Laboratories, Inc. · May 1984
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K840644 · Travenol Laboratories, S.A. · Mar 1984