Cleared Traditional

K013976 - BOEHRINGER MRI SUCTION REGULATORY

K013976 is an FDA 510(k) clearance for BOEHRINGER MRI SUCTION REGULATORY, manufactured by Boehringer Laboratories. The device is a Class 2 General Hospital device with product code KDP cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K013976 · Boehringer Laboratories · General Hospital
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Jan 2002
Decision
36d
Days
Class 2
Risk

K013976 is an FDA 510(k) clearance for the BOEHRINGER MRI SUCTION REGULATORY. Classified as Regulator, Vacuum (product code KDP), Class II - Special Controls.

Submitted by Boehringer Laboratories (Norristown, US). The FDA issued a Cleared decision on January 8, 2002 after a review of 36 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 Boehringer Laboratories devices

FDA 510(k) Submission Details - K013976

510(k) Number K013976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2001
Decision Date January 08, 2002
Days to Decision 36 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
93d faster than avg
Panel avg: 129d · This submission: 36d
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 K013976.
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
PM3000 & PM3100 VACUUM REGULATOR
K922817 · Precision Medical, Inc. · Mar 1993
OHMEDA CONTINUOUS SUCTION REGULATOR
K883229 · Ohmeda Medical · Oct 1988
VACUMATE INTERMITTENT/CONTINUOUS CONTROLLER,VM2000
K875074 · Timeter Instrument Corp. · Feb 1988