Cleared Traditional

K925058 - BARD AMBU PUMP SPIK TUB SET PACRET PROV...

K925058 is the FDA 510(k) clearance for BARD AMBU PUMP SPIK TUB SET PACRET PROV... by C.R. Bard, Inc.. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 301-day FDA review.

K925058 · C.R. Bard, Inc. · General Hospital
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Aug 1993
Decision
301d
Days
Class 2
Risk

K925058 is an FDA 510(k) clearance for the BARD AMBU PUMP SPIK TUB SET PACRET PROVID PUMP SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (North Reading, US). The FDA issued a Cleared decision on August 3, 1993 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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. Elevated predicate reliance profile. 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K925058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1992
Decision Date August 03, 1993
Days to Decision 301 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
172d slower than avg
Panel avg: 129d · This submission: 301d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPA Set, Administration, Intravascular

All 445
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K925058.
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