Cleared Traditional

K944479 - PM3300 INTERMITTENT VACUUM

K944479 is an FDA 510(k) clearance for PM3300 INTERMITTENT VACUUM, manufactured by Precision Medical, Inc.. The device is a Class 2 General Hospital device with product code KDP cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K944479 · Precision Medical, Inc. · General Hospital
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Dec 1994
Decision
100d
Days
Class 2
Risk

K944479 is an FDA 510(k) clearance for the PM3300 INTERMITTENT VACUUM. Classified as Regulator, Vacuum (product code KDP), Class II - Special Controls.

Submitted by Precision Medical, Inc. (Northampton, US). The FDA issued a Cleared decision on December 22, 1994 after a review of 100 days - within the typical 510(k) review window.

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 - K944479

510(k) Number K944479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1994
Decision Date December 22, 1994
Days to Decision 100 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
29d faster than avg
Panel avg: 129d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KDP Device Classification - Class 2, Special Controls

Product Code KDP Regulator, 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 - KDP Regulator, Vacuum

All 14
Devices cleared under the same product code (KDP) and FDA review panel - the closest regulatory comparables to K944479.
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K922817 · Precision Medical, Inc. · Mar 1993
OHMEDA CONTINUOUS SUCTION REGULATOR
K883229 · Ohmeda Medical · Oct 1988
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K875074 · Timeter Instrument Corp. · Feb 1988