Cleared Traditional

K781558 - PRESSURE MONITORING INJECTION LINES

K781558 is an FDA 510(k) clearance for PRESSURE MONITORING INJECTION LINES, manufactured by Cobe Laboratories, Inc.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K781558 · Cobe Laboratories, Inc. · Cardiovascular device
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Oct 1978
Decision
29d
Days
Class 2
Risk

K781558 is an FDA 510(k) clearance for the PRESSURE MONITORING INJECTION LINES. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Cobe Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 10, 1978 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 Cobe Laboratories, Inc. devices

FDA 510(k) Submission Details - K781558

510(k) Number K781558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1978
Decision Date October 10, 1978
Days to Decision 29 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
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 359
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K781558.
CATHETER TUBING MODIFICATION
K790107 · Jelco Laboratories · Feb 1979
POST EXTRA SYSTOLIC POTENTIATOR
K781819 · Medrad, Inc. · Jan 1979
CATHETER, DIGITAL POSITRAL II
K782082 · C.R. Bard, Inc. · Dec 1978
MYOCATH KIT
K780529 · Sorensen Research · May 1978
PRESSURE TUBING
K771810 · Pharmaseal Div., Baxter Healthcare Corp. · Nov 1977
CATHETER, POLYURETHANE, W/STYLET
K770868 · Abbott Laboratories · Jun 1977