Cleared Traditional

K982435 - IRRIGATION SYRINGE KIT

K982435 is an FDA 510(k) clearance for IRRIGATION SYRINGE KIT, manufactured by Sub-Q, Inc.. The device is a Class 1 General Hospital device with product code KYZ cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K982435 · Sub-Q, Inc. · General Hospital
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Nov 1998
Decision
116d
Days
Class 1
Risk

K982435 is an FDA 510(k) clearance for the IRRIGATION SYRINGE KIT. Classified as Syringe, Irrigating (non Dental) (product code KYZ), Class I - General Controls.

Submitted by Sub-Q, Inc. (San Clemente, US). The FDA issued a Cleared decision on November 6, 1998 after a review of 116 days - within the typical 510(k) review window.

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: 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 Sub-Q, Inc. devices

FDA 510(k) Submission Details - K982435

510(k) Number K982435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1998
Decision Date November 06, 1998
Days to Decision 116 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 129d · This submission: 116d
Pathway characteristics
Predicate-based equivalence.

KYZ Device Classification - Class 1, General Controls

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 24
Devices cleared under the same product code (KYZ) and FDA review panel - the closest regulatory comparables to K982435.
SINGLE CANNULA EXTENDED APPLICATOR
K102563 · Micromedics, Inc. · Mar 2011
TISSU-TRANS
K050797 · Shippert Medical Technologies Corp. · Jul 2005
QS DELIVERY SYSTEM
K991254 · Sub-Q, Inc. · Aug 1999
ZEROWET SPLASHIELD
K974288 · Zerowet, Inc. · Jan 1998
RMI DUAL FLUID IRRIGATING SYRINGE
K964833 · Research Medical, Inc. · Feb 1997
MARPP PRESSURE MONITORING SYSTEM
K960725 · Paradigm Medical, Inc. · Jul 1996