510(k) · Cleared
ClearedSpirol Block (19 GA. Open End Models), (20 GA. Open End Models), (19 GA. Closed End Models), (20 GA. Closed End Models)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Epimed International, Inc. · BSO Catheter, Conduction, Anesthetic
Cleared on May 28, 2014 as substantially equivalent to K981329 (Epimed International, Inc., 1998) and 1 other predicate after a 212-day review. Its family tree reaches back 5 generations to 1980. 5 of the 12 devices in its family, counting itself, have a Class I recall.
- Decided
- May 28, 2014
- Review
- 212 days
- Class
- Class II
- Product code
- BSO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K801912 (1980). 11 ancestors in all. No later device cites it as a predicate yet. 5 of the 12 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK801912 Arrow Positive Placement Con/Epidural anArrow Intl., Inc. · 1980 · Recalled (Class I)
- 4 generations backK021567 Stimucath Continuous Nerve Block Set, Product Number AB-05000Arrow Intl., Inc. · 2002 · Recalled
- 3 generations backK030937 Stimucath Continuous Nerve Block Set, Models AB-02030, AB-02060…Arrow International, Inc. · 2003 · Recalled
- 2 generations backK121403 Continuous Peripheral Nerve Block Catheter Kit and SetTeleflex, Inc. · 2012 · Recalled (Class I)
- 1 generation backK122027 Arrow Flexblock Continuous Peripheral Nerve Block CatheterArrow International, Inc. · 2012 · Recalled (Class I)
- This deviceK133316 Spirol Block (19 GA. Open End Models), (20 GA. Open End Models), (19…Epimed International, Inc. · 2014
Class I recalls in this family
- K122027 Arrow Flexblock Continuous Peripheral Nerve…direct predicate · 2012
- K121403 Continuous Peripheral Nerve Block Catheter Kit…2 generations back · 2012
- K103658 Flextip Plus Closed Tip Epidural Catherter2 generations back · 2012
- K884552 Continuous Epidural Anesthesia Kit W/Poly Catheter3 generations back · 1989
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K801912 | Arrow Positive Placement Con/Epidural an | Arrow Intl., Inc. | 1980 | Class I |
| −4 | K021567 | Stimucath Continuous Nerve Block Set, Product Number AB-05000 | Arrow Intl., Inc. | 2002 | 2 |
| −3 | K030937 | Stimucath Continuous Nerve Block Set, Models AB-02030, AB-02060, AB-02090… | Arrow International, Inc. | 2003 | 1 |
| −2 | K121403 | Continuous Peripheral Nerve Block Catheter Kit and Set | Teleflex, Inc. | 2012 | Class I |
| −1 | K122027 | Arrow Flexblock Continuous Peripheral Nerve Block Catheter | Arrow International, Inc. | 2012 | Class I |
| 0 (this device) | K133316 | Spirol Block (19 GA. Open End Models), (20 GA. Open End Models), (19 GA.… | Epimed International, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1984 | 1 | 0 |
| 1989 | 1 | 1 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2012 | 1 | 1 |
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.
5 devices in this family have 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? (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 |
|---|---|---|---|
| * | K981329 | Feth-R-KathSummary page 1…Anesthesia Conduction Catheter, BSO (21 CPR 868.5120) Predicate Device(s) Information: Predicate Device #1: Epimed International's "Feth-R-Kath" (K98 1329) e Catheter later renamed "Spirol"" by Epimed. Predicate Device #2: Arrow International'… | 1998 |
| * | K122027 | Arrow Flexblock Continuous Peripheral Nerve Block CatheterSummary page 1…Epimed. Predicate Device #2: Arrow International's "ARROW FlexBlock Continuous Peripheral Nerve Block Catheter" (K 122027) Device Description: Epimed's Spirol® Block Continuous Peripheral Nerve Block Catheter has the following char… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (5 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.
- K122027Arrow Flexblock Continuous Peripheral Nerve Block CatheterArrow International, Inc. · 2012 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K121403Continuous Peripheral Nerve Block Catheter Kit and SetTeleflex, Inc. · 2012 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K103658Flextip Plus Closed Tip Epidural CatherterTeleflex, Inc. · 2012 · 2 generations back · ◆ in the 2012 ancestors bar of FIG. 11 Class I recall
- K884552Continuous Epidural Anesthesia Kit W/Poly CatheterArrow Intl., Inc. · 1989 · 3 generations back · ◆ in the 1989 ancestors bar of FIG. 11 Class I recall
- K801912Arrow Positive Placement Con/Epidural anArrow Intl., Inc. · 1980 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 34 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 8 of the 11 ancestors have a recall of any class; 5 have a Class I recall.
- 3 other devices also cite its predicate K981329.
How does its category compare?
All BSO devicesBSO Catheter, Conduction, Anesthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Spirol® Block Continuous Peripheral Nerve Block Catheter permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques including upper extremity, lower extremity, abdominal and paravertebral locations for periods not exceeding 72 hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133316 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133316: Spirol Block (19 GA. Open End Models), (20 GA. Open End Models), (19 GA. Closed End Models), (20 GA. Closed End Models).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133316
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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