Cleared Traditional

K922817 - PM3000 & PM3100 VACUUM REGULATOR

K922817 is an FDA 510(k) clearance for PM3000 & PM3100 VACUUM REGULATOR, 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 266-day FDA review.

K922817 · Precision Medical, Inc. · General Hospital
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Mar 1993
Decision
266d
Days
Class 2
Risk

K922817 is an FDA 510(k) clearance for the PM3000 & PM3100 VACUUM REGULATOR. 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 March 4, 1993 after a review of 266 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 - K922817

510(k) Number K922817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 1992
Decision Date March 04, 1993
Days to Decision 266 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
137d slower than avg
Panel avg: 129d · This submission: 266d
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 K922817.
PM3300 INTERMITTENT VACUUM
K944479 · Precision Medical, Inc. · Dec 1994
BOEHRINGER LABORATORIES SUCTION REGULATOR, MODIFIED
K933232 · Boehringer Laboratories · Mar 1994
VACUUM POWER BODY FLUID SUCTION APPARATUS
K926140 · Hill-Rom, Inc. · Jul 1993
OHMEDA CONTINUOUS SUCTION REGULATOR
K883229 · Ohmeda Medical · Oct 1988
VACUMATE INTERMITTENT/CONTINUOUS CONTROLLER,VM2000
K875074 · Timeter Instrument Corp. · Feb 1988
BOEHRINGER LAB SUCTION INTERRUPTER
K853155 · Boehringer Laboratories · Oct 1985