510(k) · Cleared
ClearedSecurAcath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Interrad Medical, Inc. · OKC Implanted Subcutaneous Securement Catheter
Cleared on Apr 12, 2021 as substantially equivalent to K180994 (Interrad Medical, Inc., 2019) after a 41-day review. Its family tree reaches back 13 generations to 2000. 1 of the 22 devices in its family, counting itself, has a Class I recall.
- Decided
- Apr 12, 2021
- Review
- 41 days
- Class
- Class II
- Product code
- OKC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K001901 (2000). 21 ancestors in all, the oldest K862056 (1986). No later device cites it as a predicate yet. 1 of the 22 devices in this family, counting this one, has a Class I recall.
- Root · 13 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 9 generations between
- 3 generations backK120935 SecuracathInterrad Medical, Inc. · 2012
- 2 generations backK180769 SecurAcathInterrad Medical, Inc. · 2018
- 1 generation backK180994 SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F…Interrad Medical, Inc. · 2019
- This deviceK210629 SecurAcathInterrad Medical, Inc. · 2021
Show all 13 generations
- Root · 13 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 12 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 11 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 10 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
- 9 generations backK050931 6 FR DL Powerpicc CatheterC.R. Bard, Inc. · 2005
- 8 generations backK051672 PowerpiccBard Access Systems, Inc. · 2005 · Recalled
- 7 generations backK053501 PowerpiccBard Access Systems, Inc. · 2006
- 6 generations backK082047 Securacath Catheter, Model SPK01Interrad Medical, Inc. · 2008
- 5 generations backK083081 Modification to Securacath, Model: SPK01Interrad Medical, Inc. · 2009
- 4 generations backK092306 Securacath UniversalInterrad Medical, Inc. · 2010
- 3 generations backK120935 SecuracathInterrad Medical, Inc. · 2012
- 2 generations backK180769 SecurAcathInterrad Medical, Inc. · 2018
- 1 generation backK180994 SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F…Interrad Medical, Inc. · 2019
- This deviceK210629 SecurAcathInterrad Medical, Inc. · 2021
Class I recalls in this family
- K862056 [Central Venous][Multi-Lumen] Catheter W/Flex Tip8 generations back · 1986
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −12 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −11 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −10 | K034019 | Poly Per-Q-Cath Picc Catheters | C.R. Bard, Inc. | 2004 | 1 |
| −9 | K050931 | 6 FR DL Powerpicc Catheter | C.R. Bard, Inc. | 2005 | — |
| −8 | K051672 | Powerpicc | Bard Access Systems, Inc. | 2005 | 1 |
| −7 | K053501 | Powerpicc | Bard Access Systems, Inc. | 2006 | — |
| −6 | K082047 | Securacath Catheter, Model SPK01 | Interrad Medical, Inc. | 2008 | — |
| −5 | K083081 | Modification to Securacath, Model: SPK01 | Interrad Medical, Inc. | 2009 | — |
| −4 | K092306 | Securacath Universal | Interrad Medical, Inc. | 2010 | — |
| −3 | K120935 | Securacath | Interrad Medical, Inc. | 2012 | — |
| −2 | K180769 | SecurAcath | Interrad Medical, Inc. | 2018 | — |
| −1 | K180994 | SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F… | Interrad Medical, Inc. | 2019 | — |
| 0 (this device) | K210629 | SecurAcath | Interrad Medical, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 1 |
| 1994 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K180994 | SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath…Summary page 5…(KI80994). 8.7 DEVICE COMPARISON Table 8-1: Comparison of Device Characteristics to Marketed Predicate Device Items Predicate SecurAcath (K180994) SecurAcath (Current Device) Product Name Interrad Medical SecurAcath Same-No change… | 2019 |
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.
- K862056[Central Venous][Multi-Lumen] Catheter W/Flex TipArrow Intl., Inc. · 1986 · 8 generations back · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 5 of the 21 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All OKC devicesOKC Implanted Subcutaneous Securement Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · OKC
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · OKC
Too few OKC 510(k)s in any year since 2007 to give a median.
Recalls per year · OKC
No recall names OKC since 2007.
Adverse event reports per year · OKC
1in 2020
MAUDE reports naming product code OKC, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 6 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SecurAcath Device is indicated for catheter securement to the access site by means of
subcutaneous anchors in:
a) Short or long-term securement of percutaneous indwelling catheters for intravenous use
b) Short and long-term securement of percutaneous indwelling catheter for abscess/general drainage
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210629 · printed Nov 4, 2026
Cite this page
510(k) Report. “K210629: SecurAcath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K210629
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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