Cleared Traditional

K803198 - IRRIGATION SET W/PISTON SYRINGE

K803198 is the FDA 510(k) clearance for IRRIGATION SET W/PISTON SYRINGE by Walpak Co.. It is a Class 2 General Hospital device (product code FMF) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K803198 · Walpak Co. · General Hospital
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Jan 1981
Decision
29d
Days
Class 2
Risk

K803198 is an FDA 510(k) clearance for the IRRIGATION SET W/PISTON SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Walpak Co. (Mchenry, US). The FDA issued a Cleared decision on January 15, 1981 after a review of 29 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 Walpak Co. devices

Submission Details

510(k) Number K803198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1980
Decision Date January 15, 1981
Days to Decision 29 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
100d faster than avg
Panel avg: 129d · This submission: 29d
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 312
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K803198.
PREFILLED PULSATOR SYRINGE
K811009 · Concord Laboratories, Inc. · Jun 1981
PREFILLED PULSATOR SYRINGE
K810995 · Concord Laboratories, Inc. · May 1981
PISTON SYRINGE
K811065 · Sherwood Medical Co. · May 1981
CONTROL SYRINGE
K801430 · Abco Dealers, Inc. · Jul 1980
BURRON MULTI-AD SYRINGE CAP
K801311 · Burron Medical Products, Inc. · Jun 1980
DYNACOR STERILE BLOOD GAS SPECIMEN TRAY
K792033 · Medline Industries, Inc. · Nov 1979