510(k) · Cleared
ClearedSims Portex Anesthesia Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sims Portex, Inc. · FRN Pump, Infusion
Cleared on Feb 22, 2000 as substantially equivalent to K992471 (Sims Portex, Inc., 1999) and 1 other predicate after a 64-day review. Its family tree reaches back 1 generation to 1981. 1 later device descends from it.
- Decided
- Feb 22, 2000
- Review
- 64 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K813186 (1981). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K121525Perifuse CatheterSmiths Medical Asd, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K813186 | Perfix Set for Epidural Anesthesia W/Tuo | Burron Medical Products, Inc. | 1981 | — |
| 0 (this device) | K994275 | Sims Portex Anesthesia Catheter | Sims Portex, Inc. | 2000 | — |
| +1 | K121525 | Perifuse Catheter | Smiths Medical Asd, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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.
Planning a device in FRN? 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 FRN device
- #1 K253703 RemunityPRO+ Pump for Remodulin®…score 12.6 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K992471 | Sims Portex Epidural Catheter, 20G Model# 4910-16/17; 21G Model# 4910-18Summary page 2…nfusion pump) PREDICATE DEVICE(S): SIMS Portex Inc., Epidural Catheter; 4910-18, 21g nylon, closed-end, three-cyed This device is marketed under 510(k), K992471. B. Braun Medical Inc., PERIFIX® Epidural Catheter Set, EC20-C This device is marketed under 510(k), K813186 and the indications… | 1999 |
| * | K813186 | Perfix Set for Epidural Anesthesia W/TuoSummary page 2…losed-end, three-cyed This device is marketed under 510(k), K992471. B. Braun Medical Inc., PERIFIX® Epidural Catheter Set, EC20-C This device is marketed under 510(k), K813186 and the indications for use are as specified in I-Flow Corporation’s 510(k)s, K980558 and K991543. DESCRIPTION: The SIMS Portex… | 1981 |
| † | K980558 | Painbuster Infusion System | 1998 |
| † | K991543 | Intraop Catheter | 1999 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121525 | Perifuse Catheter | 2012 | 0 |
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?
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FRN
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRN
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRN
7in 2025
Class I (37 since 2007) Class II/III not classified
Adverse event reports per year · FRN
52,792in 2025
MAUDE reports naming product code FRN, 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 | 12 | 102 | 15 | 1,086 |
| 2008 | 8 | 89 | 24 | 8,261 |
| 2009 | 9 | 66 | 102 | 1,952 |
| 2010 | 3 | 93 | 37 | 6,133 |
| 2011 | 3 | 103 | 69 | 41,367 |
| 2012 | 4 | 217 | 42 (2) | 15,482 |
| 2013 | 6 | 312 | 22 (3) | 40,082 |
| 2014 | 6 | 172 | 4 (3) | 94,180 |
| 2015 | 3 | 232 | 5 | 26,742 |
| 2016 | 3 | 301 | 7 (1) | 16,560 |
| 2017 | 3 | 305 | 13 | 12,060 |
| 2018 | 3 | 267 | 1 | 16,591 |
| 2019 | 2 | — | 18 (1) | 15,850 |
| 2020 | 1 | — | 16 (5) | 94,186 |
| 2021 | 2 | — | 3 (2) | 199,342 |
| 2022 | 6 | 268 | 2 | 888,020 |
| 2023 | 7 | 265 | 16 (10) | 165,838 |
| 2024 | 5 | 103 | 9 (4) | 57,730 |
| 2025 | 8 | 172 | 7 (4) | 52,792 |
| 2026 | 2 | — | 11 (2) | — |
What is it indicated for?
The SIMS Portex Anesthesia Catheter is indicated for the infusion of local anesthetics or narcotics into the intrapperative site for post operative pain management and for regional anesthesia, outside of the epidural space. Routes of administration may include intraoperative or percutaneous. The catheter is not intended for intravenous or mtramuscular use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K994275 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994275: Sims Portex Anesthesia Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994275
Report an extraction error
Are you the manufacturer?
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