Cleared Traditional

K822774 - 9110 SYRINGE

K822774 is the FDA 510(k) clearance for 9110 SYRINGE by Cardiac Pacemakers, Inc.. It is a Class 2 General Hospital device (product code FMF) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K822774 · Cardiac Pacemakers, Inc. · General Hospital
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Nov 1982
Decision
50d
Days
Class 2
Risk

K822774 is an FDA 510(k) clearance for the 9110 SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Cardiac Pacemakers, Inc.. The FDA issued a Cleared decision on November 3, 1982 after a review of 50 days - a notably fast clearance cycle.

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: 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 Cardiac Pacemakers, Inc. devices

Submission Details

510(k) Number K822774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1982
Decision Date November 03, 1982
Days to Decision 50 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 129d · This submission: 50d
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 266
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K822774.
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DIRECTOR
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K822159 · Mallinckrodt Critical Care · Nov 1982
LARYNGEAL SYRINGE
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U-100 INSULIN SYRINGE
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K822029 · Sherwood Medical Co. · Jul 1982