Cleared Traditional

K933232 - BOEHRINGER LABORATORIES SUCTION REGULATOR

K933232 is the FDA 510(k) clearance for BOEHRINGER LABORATORIES SUCTION REGULATOR by Boehringer Laboratories. It is a Class 2 General Hospital device (product code KDP) cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K933232 · Boehringer Laboratories · General Hospital
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Mar 1994
Decision
265d
Days
Class 2
Risk

K933232 is an FDA 510(k) clearance for the BOEHRINGER LABORATORIES SUCTION REGULATOR, MODIFIED. Classified as Regulator, Vacuum (product code KDP), Class II - Special Controls.

Submitted by Boehringer Laboratories (Norristown, US). The FDA issued a Cleared decision on March 28, 1994 after a review of 265 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 Boehringer Laboratories devices

Submission Details

510(k) Number K933232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1993
Decision Date March 28, 1994
Days to Decision 265 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
136d slower than avg
Panel avg: 129d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 9
Devices cleared under the same product code (KDP) and FDA review panel - the closest regulatory comparables to K933232.
BOEHRINGER MRI SUCTION REGULATORY
K013976 · Boehringer Laboratories · Jan 2002
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
THORACIC GAUGE #TG-60 -VACUUM REGULATOR
K831505 · Sorensen Research · Jul 1983