Cleared Traditional

K011899 - PF 5050 PRESSURE UNIT, MODEL PF 5050

K011899 is an FDA 510(k) clearance for PF 5050 PRESSURE UNIT, manufactured by Perimed AB. The device is a Class 2 Cardiovascular device with product code DPW cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K011899 · Perimed AB · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2001
Decision
141d
Days
Class 2
Risk

K011899 is an FDA 510(k) clearance for the PF 5050 PRESSURE UNIT, MODEL PF 5050. Classified as Flowmeter, Blood, Cardiovascular (product code DPW), Class II - Special Controls.

Submitted by Perimed AB (Jarfalla, SE). The FDA issued a Cleared decision on November 6, 2001 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2100 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K011899

510(k) Number K011899 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2001
Decision Date November 06, 2001
Days to Decision 141 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 125d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPW Device Classification - Class 2, Special Controls

Product Code DPW Flowmeter, Blood, Cardiovascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2100
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DPW Flowmeter, Blood, Cardiovascular

All 95
Devices cleared under the same product code (DPW) and FDA review panel - the closest regulatory comparables to K011899.
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VASCULAR ASSIST
K002186 · Huntleigh Healthcare, Inc. · May 2001
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K992529 · Vital Medical , Ltd. · Nov 2000
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K984338 · Jostra Bentley · Aug 1999