510(k) Report

510(k) · Cleared

Cleared

Manan Malecot Basket Drainage Catheter

K954147510(k) TraditionalCleared Mar 26, 1996203-day reviewClass II21 CFR 876.5090

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Manan Medical Products, Inc. · FEW Catheter, Malecot

Cleared on Mar 26, 1996 after a 203-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided
Mar 26, 1996
Review
203 days
Class
Class II
Product code
FEW
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared1995200020052010201520202025
  1. This deviceK954147 Manan Malecot Basket Drainage CatheterManan Medical Products, Inc. · 1996
  2. Descendant · cites it directly · 0 of its ownK981258 Manan Malecot Basket Drainage CatheterMedical Device Technologies, Inc. · 1998

Most influential descendants

Showing 1 of 1 · See all
  • K981258Manan Malecot Basket Drainage CatheterMedical Device Technologies, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K954147Manan Malecot Basket Drainage CatheterManan Medical Products, Inc.1996—
+1K981258Manan Malecot Basket Drainage CatheterMedical Device Technologies, Inc.1998—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
FIG. 1 — Lineage of K954147, 1996–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FEW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K981258Manan Malecot Basket Drainage CatheterMedical Device Technologies, Inc.19980

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K981258 (Medical Device Technologies, Inc., 1998) has gone furthest, with 0 descendants of its own.

How does its category compare?

All FEW devices

FEW Catheter, Malecot: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FEW

1in 2014

2007: 12014: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FEW

Too few FEW 510(k)s in any year since 2007 to give a median.

Recalls per year · FEW

No recall names FEW since 2007.

Adverse event reports per year · FEW

1in 2023

2014: 12015: 32017: 22018: 12019: 42020: 32023: 1
2007high 4 (2019) · low 0 (2007)2025

MAUDE reports naming product code FEW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20141—01
20150—03
20160—00
20170—02
20180—01
20190—04
20200—03
20210—00
20220—00
20230—01
20240—00
20250—00
20260—0—

More from Manan Medical Products, Inc.

39 FDA decisions under this applicant name. See the company

  • K052802Manan Bio-Cut Soft Tissue Biopsy NeedleManan Medical Products, Inc. · 2005
  • K011209Manan Spritacre Spinal NeedlesManan Medical Products, Inc. · 2001
  • K983620Manan Spinal NeedlesManan Medical Products, Inc. · 1999
  • K980536Epidural NeedleManan Medical Products, Inc. · 1998
  • K981386Manan Blunt NeedleManan Medical Products, Inc. · 1998

Recent decisions in FEW

The FEW category page

  • K140085Universa Percultaneous Drainage CatheterCook Incorporated · 2014
  • K070879Bard Malecot and Pezzer DrainsC.R. Bard, Inc. · 2007
  • K981258Manan Malecot Basket Drainage CatheterMedical Device Technologies, Inc. · 1998
  • K954116Silicone Malecot Catheter with Pezzer/Mushroom TipTechnical Products, Inc. · 1995
  • K920423Olympic Smart Scale Care CenterOlympic Medical Corp. · 1992

https://510kreport.com/device/K954147 · printed Nov 4, 2026

Cite this page

510(k) Report. “K954147: Manan Malecot Basket Drainage Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954147

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026