Cleared Traditional

K850200 - SUCTION REGULATOR 7700 SERIES

K850200 is the FDA 510(k) clearance for SUCTION REGULATOR 7700 SERIES by Boehringer Laboratories. It is a Class 2 General Hospital device (product code KDP) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K850200 · Boehringer Laboratories · General Hospital

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Mar 1985

Decision

45d

Days

Class 2

Risk

K850200 is an FDA 510(k) clearance for the SUCTION REGULATOR 7700 SERIES. 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 4, 1985 after a review of 45 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

Submission Details

510(k) Number	K850200 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 18, 1985
Decision Date	March 04, 1985
Days to Decision	45 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

84d faster than avg

Panel avg: 129d · This submission: 45d

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 K850200.

BOEHRINGER LABORATORIES SUCTION REGULATOR, MODIFIED

K933232 · Boehringer Laboratories · Mar 1994

OHMEDA CONTINUOUS SUCTION REGULATOR

K883229 · Ohmeda Medical · Oct 1988

BOEHRINGER LAB SUCTION INTERRUPTER

K853155 · Boehringer Laboratories · Oct 1985

INTERCEPT

K843591 · Vital Signs, Inc. · Oct 1984

THORACIC GAUGE #TG-60 -VACUUM REGULATOR

K831505 · Sorensen Research · Jul 1983

CONTAINER W/PRIMING SOLUTION

K830343 · American Hospital Supply Corp. · Mar 1983

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K850200

Boehringer Laboratories

Norristown, PA · US

JOHN R BOEHRINGER

Regulatory profile

38 submissions 38 cleared

100% clearance rate · Active in General Hospital

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Sourced from FDA 510(k) public files . Updated monthly.

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