Cleared Traditional

K842005 - MODEL 110-5 & 140-8

K842005 is an FDA 510(k) clearance for MODEL 110-5 & 140-8, manufactured by Camino Laboratories, Inc.. The device is a Class 2 Cardiovascular device with product code DXO cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K842005 · Camino Laboratories, Inc. · Cardiovascular device
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Aug 1984
Decision
78d
Days
Class 2
Risk

K842005 is an FDA 510(k) clearance for the MODEL 110-5 & 140-8. Classified as Transducer, Pressure, Catheter Tip (product code DXO), Class II - Special Controls.

Submitted by Camino Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on August 3, 1984 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2870 - 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 Camino Laboratories, Inc. devices

FDA 510(k) Submission Details - K842005

510(k) Number K842005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1984
Decision Date August 03, 1984
Days to Decision 78 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
47d faster than avg
Panel avg: 125d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXO Device Classification - Class 2, Special Controls

Product Code DXO Transducer, Pressure, Catheter Tip
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2870
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 - DXO Transducer, Pressure, Catheter Tip

All 57
Devices cleared under the same product code (DXO) and FDA review panel - the closest regulatory comparables to K842005.
MODEL P23XL PHYSIOLOGICAL PRESSURE TRANSDUCER
K843969 · Gould, Inc. · Jan 1985
TRANSDUCER-MONITOR INTERFACING
K842150 · Millar Instruments, Inc. · Oct 1984
VSM R1
K842213 · Physio-Control Corp. · Oct 1984
MINATURE PRESSURE TRANSDUCER
K834040 · Carbomedics, Inc. · Feb 1984
BP TRANSDUCER HOLDERS TH-2,3 & 4
K832384 · American Bentley · Nov 1983
PHYSIOLOGICAL PRESS. MEASUREMENT CATH
K832579 · Camino Laboratories, Inc. · Oct 1983