Cleared Traditional

K902622 - MANAN PROSTATE SEEDING NEEDLE

K902622 is the FDA 510(k) clearance for MANAN PROSTATE SEEDING NEEDLE by Manan Medical Products, Inc.. It is a Class 2 Radiology device (product code KXK) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K902622 · Manan Medical Products, Inc. · Radiology device
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Aug 1990
Decision
57d
Days
Class 2
Risk

K902622 is an FDA 510(k) clearance for the MANAN PROSTATE SEEDING NEEDLE. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Manan Medical Products, Inc. (Northbrook, US). The FDA issued a Cleared decision on August 10, 1990 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5730 - the FDA radiology and imaging software oversight 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 Manan Medical Products, Inc. devices

Submission Details

510(k) Number K902622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1990
Decision Date August 10, 1990
Days to Decision 57 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 107d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KXK Source, Brachytherapy, Radionuclide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5730
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 Radiology devices follow this clearance model.

Regulatory Peers - KXK Source, Brachytherapy, Radionuclide

All 30
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K902622.
MODIFICATION TO ACCU-SPACE PLAIN GUT ABSORBABLE SEEDING SPACERS
K013964 · Cp Medical · Jan 2002
ACCU-SPACE ABSORBABLE SEEDING SPACERS
K010621 · Cp Medical · Sep 2001
RADIONUCLIDE CATHETERS, RNC-A, RNC-G, RNC-U
K923697 · Radionics, Inc. · Dec 1993
CESIUM 137 ENDOMETRIAL SOURCE
K850433 · Syncor Intl. Corp. · Aug 1985
CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-41
K852023 · Syncor Intl. Corp. · Aug 1985
CS137 SEALED SOURCES
K850434 · Syncor Intl. Corp. · Mar 1985