Cleared Traditional

K850861 - ROENTGENOGRAPHY SET & PRESSURE MONITORI...

K850861 is an FDA 510(k) clearance for ROENTGENOGRAPHY SET & PRESSURE MONITORI..., manufactured by Medical Components, Inc.. The device is a Class 2 Cardiovascular device with product code DXT cleared through the Traditional 510(k) pathway after a 354-day FDA review.

K850861 · Medical Components, Inc. · Cardiovascular device
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Feb 1986
Decision
354d
Days
Class 2
Risk

K850861 is an FDA 510(k) clearance for the ROENTGENOGRAPHY SET & PRESSURE MONITORING LINE. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Medical Components, Inc. (Harleysville, US). The FDA issued a Cleared decision on February 18, 1986 after a review of 354 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1650 - 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Medical Components, Inc. devices

FDA 510(k) Submission Details - K850861

510(k) Number K850861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1985
Decision Date February 18, 1986
Days to Decision 354 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
229d slower than avg
Panel avg: 125d · This submission: 354d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXT Device Classification - Class 2, Special Controls

Product Code DXT Injector And Syringe, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1650
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 - DXT Injector And Syringe, Angiographic

All 110
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K850861.
MECHANICAL INFLATION DEVICE
K862547 · American Edwards Laboratories · Sep 1986
ANGIOMAT 6000
K860204 · Mallinckrodt Group, Inc. · May 1986
ANGIOJECT
K860842 · Target Therapeutics · Apr 1986
ACS INDEFLATOR (MODIFICATION)
K854310 · Advanced Cardiovascular Systems, Inc. · Dec 1985
LEVEEN INFLATOR DISPOSABLE INFLATION SYRINGE
K851402 · Medi-Tech, Inc. · Jun 1985
ADVANCED CARDIOVASCULAR SYSTEMS ANGIOJECT
K844045 · Advanced Cardiovascular Systems, Inc. · Nov 1984