Cleared Traditional

K910963 - THOROCENTESIS KIT

K910963 is an FDA 510(k) clearance for THOROCENTESIS KIT, manufactured by Megadyne Medical Products, Inc.. The device is a Class 2 General Hospital device with product code JOL cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K910963 · Megadyne Medical Products, Inc. · General Hospital
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Jun 1991
Decision
106d
Days
Class 2
Risk

K910963 is an FDA 510(k) clearance for the THOROCENTESIS KIT. Classified as Catheter And Tip, Suction (product code JOL), Class II - Special Controls.

Submitted by Megadyne Medical Products, Inc. (Hauppauge, US). The FDA issued a Cleared decision on June 20, 1991 after a review of 106 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6740 - 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 Megadyne Medical Products, Inc. devices

FDA 510(k) Submission Details - K910963

510(k) Number K910963 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received March 06, 1991
Decision Date June 20, 1991
Days to Decision 106 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
23d faster than avg
Panel avg: 129d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOL Device Classification - Class 2, Special Controls

Product Code JOL Catheter And Tip, Suction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6740
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 - JOL Catheter And Tip, Suction

All 49
Devices cleared under the same product code (JOL) and FDA review panel - the closest regulatory comparables to K910963.
THORA-CATH
K941232 · Gesco Intl., Inc. · May 1994
STERILE WATER
K933526 · Trinity Laboratories, Inc. · Mar 1994
PHARMASEAL THORACENTESIS TRAY W/UNIV DRAINAGE SET
K910693 · Baxter Healthcare Corp · Oct 1991
CURITY THORACENTESIS TRAY
K903569 · Kendall Healthcare Products Co. Div.Of Tyco Health · Sep 1990
KLEEN TEST BASIN SET
K890039 · Kleen Test Products · Oct 1989
LAPAROSCOPIC SUCTION PROBE
K893527 · Dexide, Inc. · Jul 1989