Cleared Traditional

K813027 - STERILE IRRIGATING SYRINGES

K813027 is the FDA 510(k) clearance for STERILE IRRIGATING SYRINGES by Welcon, Inc.. It is a Class 1 General Hospital device (product code KYZ) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K813027 · Welcon, Inc. · General Hospital
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Nov 1981
Decision
23d
Days
Class 1
Risk

K813027 is an FDA 510(k) clearance for the STERILE IRRIGATING SYRINGES, KITS,TRAY. Classified as Syringe, Irrigating (non Dental) (product code KYZ), Class I - General Controls.

Submitted by Welcon, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 20, 1981 after a review of 23 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6960 - 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 Welcon, Inc. devices

Submission Details

510(k) Number K813027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1981
Decision Date November 20, 1981
Days to Decision 23 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
106d faster than avg
Panel avg: 129d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KYZ Syringe, Irrigating (non Dental)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6960
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KYZ Syringe, Irrigating (non Dental)

All 12
Devices cleared under the same product code (KYZ) and FDA review panel - the closest regulatory comparables to K813027.
SURGICAL SEALANT APPLICATOR
K883338 · Micromedics, Inc. · Aug 1988
SURGICAL SEALANT DISPENSER (SSD)
K881020 · Micromedics, Inc. · Mar 1988
CLEAN-FLUSH
K830572 · Burron Medical Products, Inc. · Mar 1983
IRRIJET
K810209 · Ackrad Laboratories · Feb 1981
IRRIGATION CAP
K780794 · Travenol Laboratories, S.A. · Jul 1978