510(k) · Cleared
ClearedPerifix One Pediatric Catheter, 20 GA. & 24 GA.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B.Braun Medical, Inc. · BSO Catheter, Conduction, Anesthetic
Cleared on Jun 29, 2009 as substantially equivalent to K042488 (B.Braun Medical, Inc., 2004) and 2 other predicates after a 90-day review. Its family tree reaches back 6 generations to 1990. 1 of the 26 devices in its family, counting itself, has a Class I recall.
- Decided
- Jun 29, 2009
- Review
- 90 days
- Class
- Class II
- Product code
- BSO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K896422 (1990). 25 ancestors in all, the oldest K801912 (1980). No later device cites it as a predicate yet. 1 of the 26 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK896422 Burron Ambulatory Drug Delivery SystemBurron Medical, Inc. · 1990
- 5 generations backK980558 Painbuster Infusion SystemI-Flow Corp. · 1998
- 4 generations backK982946 Painbuster Infusion KitI-Flow Corp. · 1998
- 3 generations backK984502 Nerve Block Infusion KitI-Flow Corp. · 1999
- 2 generations backK030830 B. Braun Nerve Block CatheterB.Braun Medical, Inc. · 2003
- 1 generation backK042488 Perifix Catheter and Contiplex CatheterB.Braun Medical, Inc. · 2004
- This deviceK090884 Perifix One Pediatric Catheter, 20 GA. & 24 GA.B.Braun Medical, Inc. · 2009
Class I recalls in this family
- K801912 Arrow Positive Placement Con/Epidural an4 generations back · 1980
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K896422 | Burron Ambulatory Drug Delivery System | Burron Medical, Inc. | 1990 | — |
| −5 | K980558 | Painbuster Infusion System | I-Flow Corp. | 1998 | — |
| −4 | K982946 | Painbuster Infusion Kit | I-Flow Corp. | 1998 | — |
| −3 | K984502 | Nerve Block Infusion Kit | I-Flow Corp. | 1999 | — |
| −2 | K030830 | B. Braun Nerve Block Catheter | B.Braun Medical, Inc. | 2003 | — |
| −1 | K042488 | Perifix Catheter and Contiplex Catheter | B.Braun Medical, Inc. | 2004 | — |
| 0 (this device) | K090884 | Perifix One Pediatric Catheter, 20 GA. & 24 GA. | B.Braun Medical, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 1 |
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. 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 K241410 EDEN ControlCathscore 9.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K042488 | Perifix Catheter and Contiplex CatheterSummary page 1…Class II, Product Code BSO, 21 CFR 868.5120 PREDICATE DEVICES: B. Braun Medical Regional Anesthesia Catheter (K042488), Smiths Medical ASD, Inc. Portex ®24 Ga. Pediatric Epidural and Peripheral Block Anesthesia… | 2004 |
| * | K033080 | Portex 24G Pediatric Epidural and Peripheral Block Anesthesia CatheterSummary page 1…2488), Smiths Medical ASD, Inc. Portex ®24 Ga. Pediatric Epidural and Peripheral Block Anesthesia Catheter (K033080) PAJUNK Pediatric epidural catheter (K062902) DESCRIPTION: B. Braun's Perifix ON… | 2004 |
| * | K062902 | Pajunks Epilong Set PediatricSummary page 1…Pediatric Epidural and Peripheral Block Anesthesia Catheter (K033080) PAJUNK Pediatric epidural catheter (K062902) DESCRIPTION: B. Braun's Perifix ONE® Pediatric Catheter is a co- extruded anesth… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K801912Arrow Positive Placement Con/Epidural anArrow Intl., Inc. · 1980 · 4 generations back · ◆ in the 1980 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
- 3 of the 25 ancestors have a recall of any class; 1 has a Class I recall.
- 5 other devices also cite its predicate K042488.
How does its category compare?
All BSO devicesBSO Catheter, Conduction, Anesthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · BSO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BSO
205in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BSO
2so far in 2026, the most since 2007
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · BSO
139in 2025
MAUDE reports naming product code BSO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 18 |
| 2008 | 3 | 155 | 0 | 14 |
| 2009 | 1 | — | 1 | 71 |
| 2010 | 1 | — | 0 | 57 |
| 2011 | 4 | 109 | 0 | 31 |
| 2012 | 0 | — | 0 | 52 |
| 2013 | 1 | — | 0 | 73 |
| 2014 | 2 | — | 0 | 45 |
| 2015 | 1 | — | 0 | 43 |
| 2016 | 5 | 281 | 0 | 71 |
| 2017 | 3 | 205 | 0 | 38 |
| 2018 | 2 | — | 0 | 80 |
| 2019 | 2 | — | 0 | 779 |
| 2020 | 2 | — | 0 | 159 |
| 2021 | 0 | — | 0 | 146 |
| 2022 | 0 | — | 0 | 135 |
| 2023 | 2 | — | 0 | 79 |
| 2024 | 0 | — | 0 | 98 |
| 2025 | 1 | — | 0 | 139 |
| 2026 | 0 | — | 2 (1) | — |
What is it indicated for?
The B. Braun Perifix ONE® Pediatric Catheter is intended to provide, via percutaneous administration, continuous and/or intermittent infusion of local anesthetics and analgesics in the epidural space or near a nerve for regional anesthesia and pain management during the preoperative, perioperative and postoperative periods associated with general and orthopedic surgery for pediatric patients within the subgroups of Child (2 to 12 years of, age) and Adolescent (12 to 21 years of age). Routes of Administration include epidural and perineural (peripheral nerve block) with a duration of use no longer than 72 hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090884 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090884: Perifix One Pediatric Catheter, 20 GA. & 24 GA..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090884
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026