510(k) Report

510(k) · Decided

Decided

Epidural Minipack

K924541510(k) TraditionalDecided Jul 9, 1993304-day reviewClass I21 CFR 868.5220

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

Concord/Portex · BYO Bottle, Blow

Cleared on Jul 9, 1993 after a 304-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Jul 9, 1993
Review
304 days
Class
Class I
Product code
BYO
Recalls
None
Predicates
0

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

Descendants, by year cleared 2004: 1 descendant cleared2007: 1 descendant cleared2009: 1 descendant cleared1990200020102020
  1. This deviceK924541 Epidural MinipackConcord/Portex · 1993
  2. Descendant · cites it directly · 2 of its ownK033080 Portex 24G Pediatric Epidural and Peripheral Block Anesthesia CatheterPortex, Inc. · 2004
  3. Descendant · 2 generations on · 1 of its ownK062902 Pajunks Epilong Set PediatricPAJUNK GmbH Medizintechnologie · 2007
  4. 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 3 of 3 · See all
  • K033080Portex 24G Pediatric Epidural and Peripheral Block Anesthesia CatheterPortex, Inc. · 2004 · cites it directly2descendants
  • K062902Pajunks Epilong Set PediatricPAJUNK GmbH Medizintechnologie · 2007 · 2 generations on1descendant
  • 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)K924541Epidural MinipackConcord/Portex1993—
+1K033080Portex 24G Pediatric Epidural and Peripheral Block Anesthesia CatheterPortex, Inc.2004—
+2K062902Pajunks 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
200410
200710
200910
FIG. 1 — Lineage of K924541, 1993–2009Source: 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 BYO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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  • Recall history across each candidate’s familyin the report
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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? (3)

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

NumberDeviceApplicantDecidedDescendants
K033080Portex 24G Pediatric Epidural and Peripheral Block Anesthesia CatheterPortex, Inc.20042

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, K033080 (Portex, Inc., 2004) has gone furthest, with 2 descendants of its own.

How does its category compare?

All BYO devices

BYO Bottle, Blow: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BYO

FDA has decided no BYO device since 2007.

Median 510(k) review, days · BYO

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

Recalls per year · BYO

No recall names BYO since 2007.

Adverse event reports per year · BYO

No MAUDE report names BYO since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Concord/Portex

23 FDA decisions under this applicant name. See the company

  • K923559Steri-Cath MdiConcord/Portex · 1993
  • K930218Subcutaneous Tunneling Needle and HandlesConcord/Portex · 1993
  • K930286Dri-Vendt/Provent/Accuvent Arterial Blood Gas KitsConcord/Portex · 1993
  • K923127Needle-Pro CartridgeConcord/Portex · 19931 recall
  • K923910Heat Moisture CondenserConcord/Portex · 1993

Recent decisions in BYO

The BYO category page

  • K913527HyperfreeKist Intl. · 1992
  • K780558Bottle Breathing DeviceB & F Medical Products, Inc. · 1978
  • K7804072C7125 Blow BottleTravenol Laboratories, S.A. · 1978

https://510kreport.com/device/K924541 · printed Nov 5, 2026

Cite this page

510(k) Report. “K924541: Epidural Minipack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K924541

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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