Cleared Traditional

BARD INTRA-ABDOMINAL PRESSURE MONITORING DEVICE, MODEL IAP-001 (K070201) - FDA 510(k) Clearance

K070201 · C.R. Bard, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
191d
Days
-
Risk

K070201 is an FDA 510(k) clearance for the BARD INTRA-ABDOMINAL PRESSURE MONITORING DEVICE, MODEL IAP-001. Classified as Intra-abdominal Pressure Monitoring Device (product code PHU).

Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on August 1, 2007 after a review of 191 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all C.R. Bard, Inc. devices

Submission Details

510(k) Number K070201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2007
Decision Date August 01, 2007
Days to Decision 191 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d slower than avg
Panel avg: 115d · This submission: 191d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code PHU Intra-abdominal Pressure Monitoring Device
Device Class -
Definition Abdominal Intracompartmental Pressure Monitoring Using Bladder Pressure As A Surrogate For Abdominal Pressure.