Cleared Traditional

ANGIOUROGRAPHY KIT (K822159) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K822159 · Mallinckrodt Critical Care · General Hospital
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Nov 1982
Decision
103d
Days
Class 2
Risk

K822159 is an FDA 510(k) clearance for the ANGIOUROGRAPHY KIT. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Mallinckrodt Critical Care (Mchenry, US). The FDA issued a Cleared decision on November 3, 1982 after a review of 103 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Mallinckrodt Critical Care devices

Submission Details

510(k) Number K822159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1982
Decision Date November 03, 1982
Days to Decision 103 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 129d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 General Hospital devices follow this clearance model.

Regulatory Peers - FMF Syringe, Piston

All 223
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K822159.
MONOJECT STERILE 12CC SYRINGES, W/WO NEEDLES
K851089 · Sherwood Medical Co. · Apr 1985
MONOJECT STERILE 1/2 CC & 1CC SYRINGES W & W/O NEE
K851090 · Sherwood Medical Co. · Apr 1985
HYPODERMIC SYRINGES & NEEDLES
K834548 · Cordis Corp. · Mar 1984
U-100 INSULIN SYRINGE
K822083 · Terumo Medical Corp. · Aug 1982
MONOJET 520 20CC SYRINGES W/NEEDLES
K822029 · Sherwood Medical Co. · Jul 1982
MONOJECT 512 SYRINGES W/WO NEEDLES
K820716 · Sherwood Medical Co. · Apr 1982