Cleared Traditional

K941818 - PM9000 VAC TRAP

K941818 is an FDA 510(k) clearance for PM9000 VAC TRAP, manufactured by Precision Medical, Inc.. The device is a Class 2 General Hospital device with product code KDQ cleared through the Traditional 510(k) pathway after a 243-day FDA review.

K941818 · Precision Medical, Inc. · General Hospital
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Dec 1994
Decision
243d
Days
Class 2
Risk

K941818 is an FDA 510(k) clearance for the PM9000 VAC TRAP. Classified as Bottle, Collection, Vacuum (product code KDQ), Class II - Special Controls.

Submitted by Precision Medical, Inc. (Northampton, US). The FDA issued a Cleared decision on December 12, 1994 after a review of 243 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6740 - 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 Precision Medical, Inc. devices

FDA 510(k) Submission Details - K941818

510(k) Number K941818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1994
Decision Date December 12, 1994
Days to Decision 243 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
114d slower than avg
Panel avg: 129d · This submission: 243d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KDQ Device Classification - Class 2, Special Controls

Product Code KDQ Bottle, Collection, Vacuum
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6740
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 - KDQ Bottle, Collection, Vacuum

All 34
Devices cleared under the same product code (KDQ) and FDA review panel - the closest regulatory comparables to K941818.
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