Cleared Traditional

K926140 - VACUUM POWER BODY FLUID SUCTION APPARATUS

K926140 is the FDA 510(k) clearance for VACUUM POWER BODY FLUID SUCTION APPARATUS by Hill-Rom, Inc.. It is a Class 2 General Hospital device (product code KDP) cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K926140 · Hill-Rom, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1993
Decision
232d
Days
Class 2
Risk

K926140 is an FDA 510(k) clearance for the VACUUM POWER BODY FLUID SUCTION APPARATUS. Classified as Regulator, Vacuum (product code KDP), Class II - Special Controls.

Submitted by Hill-Rom, Inc. (Batesville, US). The FDA issued a Cleared decision on July 27, 1993 after a review of 232 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 Hill-Rom, Inc. devices

Submission Details

510(k) Number K926140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1992
Decision Date July 27, 1993
Days to Decision 232 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d slower than avg
Panel avg: 129d · This submission: 232d
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 10
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INTERCEPT
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