Cleared Traditional

K952887 - NOPROFILE OLBERT CATHETER SYSTEM BALLOO...

K952887 · Meadox Medicals, Div. Boston Scientific Corp. · Gastroenterology & Urology device

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Aug 1995

Decision

56d

Days

Risk

K952887 is an FDA 510(k) clearance for the NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER. Classified as Catheter, Nephrostomy (product code LJE).

Submitted by Meadox Medicals, Div. Boston Scientific Corp. (Oakland, US). The FDA issued a Cleared decision on August 18, 1995 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel. 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 Meadox Medicals, Div. Boston Scientific Corp. devices

Submission Details

510(k) Number	K952887 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 23, 1995
Decision Date	August 18, 1995
Days to Decision	56 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

74d faster than avg

Panel avg: 130d · This submission: 56d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	LJE Catheter, Nephrostomy
Device Class	-

Regulatory Peers - LJE Catheter, Nephrostomy

All 49

Devices cleared under the same product code (LJE) and FDA review panel - the closest regulatory comparables to K952887.

MANAN UNIVERSAL SUMP DRAINAGE CATHETER

K953601 · Manan Medical Products, Inc. · Mar 1996

MANAN GENERAL UTILITY DRAINAGE CATHETER

K953713 · Manan Medical Products, Inc. · Mar 1996

MANAN NEPHROSTOMY DRAINAGE CATHETER

K953547 · Manan Medical Products, Inc. · Aug 1995

DILATATION CATHETER, BALLOON

K952968 · Boston Scientific Corp · Aug 1995

NEPHRO-URETERAL STENT

K942688 · Uresil Corp. · Jun 1995

PERCUTANEOUS GRAINAGE CATHETER

K943893 · Menlo Care, Inc. · Mar 1995

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K952887

Meadox Medicals, Div. Boston Scientific Corp.

Oakland, NJ · US

STEPHEN B ANDERSON

Regulatory profile

53 submissions 47 cleared

89% clearance rate · Active in Gastroenterology & Urology

Data Intelligence Layer

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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