Cleared Traditional

K011741 - CRIT-LINE MONITOR III TQA (CLM TQA)

K011741 is an FDA 510(k) clearance for CRIT-LINE MONITOR III TQA (CLM TQA), manufactured by Hemametrics. The device is a Class 2 Gastroenterology & Urology device with product code FIL cleared through the Traditional 510(k) pathway after a 413-day FDA review.

K011741 · Hemametrics · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
413d
Days
Class 2
Risk

K011741 is an FDA 510(k) clearance for the CRIT-LINE MONITOR III TQA (CLM TQA). Classified as System, Dialysate Delivery, Single Pass (product code FIL), Class II - Special Controls.

Submitted by Hemametrics (Kaysville, US). The FDA issued a Cleared decision on July 23, 2002 after a review of 413 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - the FDA gastroenterology and urology 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Hemametrics devices

FDA 510(k) Submission Details - K011741

510(k) Number K011741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2001
Decision Date July 23, 2002
Days to Decision 413 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
283d slower than avg
Panel avg: 130d · This submission: 413d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FIL Device Classification - Class 2, Special Controls

Product Code FIL System, Dialysate Delivery, Single Pass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FIL System, Dialysate Delivery, Single Pass

Devices cleared under the same product code (FIL) and FDA review panel - the closest regulatory comparables to K011741.
SPS 550-IPS (INTEGRATED PATIENT STATION)
K901038 · Baxter Healthcare Corp · Apr 1990
FRESENIUS 2008 BSS BEDSIDE DIALYSIS SYSTEM
K890329 · Fresenius USA, Inc. · May 1989
ULTRAFILTRATION SCALE
K781633 · Extracorporeal Medical Specialities, Inc. · Dec 1978
ULTRAFILTRATION MONITOR 5M9034
K771875 · Travenol Laboratories, S.A. · Nov 1977
AK-10
K771227 · Gambro, Inc. · Aug 1977
NEGATIVE PRESSURE ADAPTER 5M1350
K770137 · Travenol Laboratories, S.A. · Feb 1977