Cleared Traditional

K875074 - VACUMATE INTERMITTENT/CONTINUOUS CONTROLLER,VM2000

K875074 is an FDA 510(k) clearance for VACUMATE INTERMITTENT/CONTINUOUS CONTROLLER, manufactured by Timeter Instrument Corp.. The device is a Class 2 General Hospital device with product code KDP cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K875074 · Timeter Instrument Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1988
Decision
75d
Days
Class 2
Risk

K875074 is an FDA 510(k) clearance for the VACUMATE INTERMITTENT/CONTINUOUS CONTROLLER,VM2000. Classified as Regulator, Vacuum (product code KDP), Class II - Special Controls.

Submitted by Timeter Instrument Corp. (Lancaster, US). The FDA issued a Cleared decision on February 22, 1988 after a review of 75 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Timeter Instrument Corp. devices

FDA 510(k) Submission Details - K875074

510(k) Number K875074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1987
Decision Date February 22, 1988
Days to Decision 75 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
54d faster than avg
Panel avg: 129d · This submission: 75d
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 K875074.
VACUUM POWER BODY FLUID SUCTION APPARATUS
K926140 · Hill-Rom, Inc. · Jul 1993
PM3000 & PM3100 VACUUM REGULATOR
K922817 · Precision Medical, Inc. · Mar 1993
OHMEDA CONTINUOUS SUCTION REGULATOR
K883229 · Ohmeda Medical · Oct 1988
BOEHRINGER LAB SUCTION INTERRUPTER
K853155 · Boehringer Laboratories · Oct 1985
SUCTION REGULATOR 7700 SERIES
K850200 · Boehringer Laboratories · Mar 1985
INTERCEPT
K843591 · Vital Signs, Inc. · Oct 1984