510(k) Report

510(k) · Cleared

Cleared

Bio-Mate (TM) Pediatric Epidural Catheter

K901129510(k) TraditionalCleared Mar 30, 199018-day reviewClass II21 CFR 868.5120

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

Medevice, Inc. · BSO Catheter, Conduction, Anesthetic

Cleared on Mar 30, 1990 after an 18-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Mar 30, 1990
Review
18 days
Class
Class II
Product code
BSO
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2009: 1 descendant cleared1990200020102020
  1. This deviceK901129 Bio-Mate (TM) Pediatric Epidural CatheterMedevice, Inc. · 1990
  2. Descendant · cites it directly · 1 of its ownK062902 Pajunks Epilong Set PediatricPAJUNK GmbH Medizintechnologie · 2007
  3. Descendant · 2 generations on · 0 of its ownK090884 Perifix One Pediatric Catheter, 20 GA. & 24 GA.B.Braun Medical, Inc. · 2009

Most influential descendants

Showing 2 of 2 · See all
  • K062902Pajunks Epilong Set PediatricPAJUNK GmbH Medizintechnologie · 2007 · cites it directly1descendant
  • K090884Perifix One Pediatric Catheter, 20 GA. & 24 GA.B.Braun Medical, Inc. · 2009 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K901129Bio-Mate (TM) Pediatric Epidural CatheterMedevice, Inc.1990—
+1K062902Pajunks Epilong Set PediatricPAJUNK GmbH Medizintechnologie2007—
+2K090884Perifix One Pediatric Catheter, 20 GA. & 24 GA.B.Braun Medical, Inc.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200910
FIG. 1 — Lineage of K901129, 1990–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Top candidate predicates for a new BSO device

  1. #1 K241410 EDEN ControlCathscore 9.5 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K062902Pajunks Epilong Set PediatricPAJUNK GmbH Medizintechnologie20071

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, K062902 (PAJUNK GmbH Medizintechnologie, 2007) has gone furthest, with 1 descendant of its own.

How does its category compare?

All BSO devices

BSO Catheter, Conduction, Anesthetic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BSO

1in 2025

2007: 22008: 32009: 12010: 12011: 42013: 12014: 22015: 12016: 52017: 32018: 22019: 22020: 22023: 22025: 1
2007high 5 (2016) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BSO

205in 2017

2008: 155 days median2011: 109 days median2016: 281 days median2017: 205 days median
2007high 281 (2016) · low 109 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · BSO

2so far in 2026, the most since 2007

2009: 12026 (partial year): 2, 1 Class I
2007high 2 (2026) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · BSO

139in 2025

2007: 182008: 142009: 712010: 572011: 312012: 522013: 732014: 452015: 432016: 712017: 382018: 802019: 7792020: 1592021: 1462022: 1352023: 792024: 982025: 139
2007high 779 (2019) · low 14 (2008)2025

MAUDE reports naming product code BSO, 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
20072—018
20083155014
20091—171
20101—057
20114109031
20120—052
20131—073
20142—045
20151—043
20165281071
20173205038
20182—080
20192—0779
20202—0159
20210—0146
20220—0135
20232—079
20240—098
20251—0139
20260—2 (1)—

More from Medevice, Inc.

5 FDA decisions under this applicant name. See the company

  • K072550Sightsure Operational Indicator, Model SS301Medevice, Inc. · 2007
  • K920638Bio-Mate Pic CatheterMedevice, Inc. · 1993
  • K912856Mede-Flo I.V. Extension SetMedevice, Inc. · 1991
  • K884969Bio-Mate (TM) Epidural CatheterMedevice, Inc. · 1989

Recent decisions in BSO

The BSO category page

  • K241410EDEN ControlCathJmt Co., Ltd. · 2025
  • K231242Perifix FX Catheter; Contiplex FX CatheterB.Braun Medical, Inc. · 2023
  • K230603Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer…Teleflex Medical · 2023
  • K193664SubQKath Catheter and Needle SetHk Surgical · 2020
  • K200624Percutaneous IntroducerEpimed International, Inc. · 2020

https://510kreport.com/device/K901129 · printed Nov 3, 2026

Cite this page

510(k) Report. “K901129: Bio-Mate (TM) Pediatric Epidural Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K901129

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