Cleared Traditional

K830909 - MIKRO-TIP CATH. PRESSURE TRANSDUCER

K830909 is an FDA 510(k) clearance for MIKRO-TIP CATH. PRESSURE TRANSDUCER, manufactured by Millar Instruments, Inc.. The device is a Class 2 Cardiovascular device with product code KRB cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K830909 · Millar Instruments, Inc. · Cardiovascular device
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Apr 1983
Decision
28d
Days
Class 2
Risk

K830909 is an FDA 510(k) clearance for the MIKRO-TIP CATH. PRESSURE TRANSDUCER. Classified as Probe, Thermodilution (product code KRB), Class II - Special Controls.

Submitted by Millar Instruments, Inc. (Walker, US). The FDA issued a Cleared decision on April 18, 1983 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1915 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Millar Instruments, Inc. devices

FDA 510(k) Submission Details - K830909

510(k) Number K830909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1983
Decision Date April 18, 1983
Days to Decision 28 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRB Device Classification - Class 2, Special Controls

Product Code KRB Probe, Thermodilution
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1915
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 - KRB Probe, Thermodilution

All 24
Devices cleared under the same product code (KRB) and FDA review panel - the closest regulatory comparables to K830909.
FLOW DIRECTED THERMODILUTION CATH W/VEN
K843412 · Andover Medical, Inc. · Nov 1984
HEPARIN COATED THERMODILUTION CATHETERS
K840824 · Gould, Inc. · May 1984
THERMODILUTION CATHETER
K840992 · Gould, Inc. · May 1984
FLOW-DIRECTED THERMODILUTION CATHETER
K812800 · Sorensen Research · Oct 1981
MODEL SP 5507 5-LUMEN THERMODILUTION CAT
K811537 · Gould, Inc. · Jun 1981
SWAN-GANZ HEPARIN COATED, ETC. CATHETER
K811411 · American Edwards Laboratories · Jun 1981