Cleared Traditional

K910089 - MEGA LUMBAR PUNCTURE KIT

K910089 is an FDA 510(k) clearance for MEGA LUMBAR PUNCTURE KIT, manufactured by Megadyne Medical Products, Inc.. The device is a Class 2 General Hospital device with product code FMJ cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K910089 · Megadyne Medical Products, Inc. · General Hospital
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Jun 1991
Decision
162d
Days
Class 2
Risk

K910089 is an FDA 510(k) clearance for the MEGA LUMBAR PUNCTURE KIT. Classified as Manometer, Spinal-fluid (product code FMJ), Class II - Special Controls.

Submitted by Megadyne Medical Products, Inc. (Tampa, US). The FDA issued a Cleared decision on June 20, 1991 after a review of 162 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2500 - 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 - K910089

510(k) Number K910089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received January 09, 1991
Decision Date June 20, 1991
Days to Decision 162 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
33d slower than avg
Panel avg: 129d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMJ Device Classification - Class 2, Special Controls

Product Code FMJ Manometer, Spinal-fluid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2500
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.