510(k) · Cleared
ClearedModification to Securacath, Model: SPK01
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 Mar 4, 2009 as substantially equivalent to K082047 (Interrad Medical, Inc., 2008) and 1 other predicate after a 139-day review. Its family tree reaches back 8 generations to 2000. 1 of the 22 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Mar 4, 2009
- Review
- 139 days
- Class
- Class II
- Product code
- OKC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K001901 (2000). 16 ancestors in all, the oldest K862056 (1986). 5 later devices descend from it, 1 citing it directly. 1 of the 22 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 7 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 6 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 5 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
- 4 generations backK050931 6 FR DL Powerpicc CatheterC.R. Bard, Inc. · 2005
- 3 generations backK051672 PowerpiccBard Access Systems, Inc. · 2005 · Recalled
- 2 generations backK053501 PowerpiccBard Access Systems, Inc. · 2006
- 1 generation backK082047 Securacath Catheter, Model SPK01Interrad Medical, Inc. · 2008
- This deviceK083081 Modification to Securacath, Model: SPK01Interrad Medical, Inc. · 2009
- Descendant · cites it directly · 4 of its ownK092306 Securacath UniversalInterrad Medical, Inc. · 2010
- Descendant · 2 generations on · 3 of its ownK120935 SecuracathInterrad Medical, Inc. · 2012
- Descendant · 3 generations on · 2 of its ownK180769 SecurAcathInterrad Medical, Inc. · 2018
- Descendant · 4 generations on · 1 of its ownK180994 SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F…Interrad Medical, Inc. · 2019
- Descendant · 5 generations on · 0 of its ownK210629 SecurAcathInterrad Medical, Inc. · 2021
Class I recalls in this family
- K862056 [Central Venous][Multi-Lumen] Catheter W/Flex Tip4 generations back · 1986
Most influential descendants
Showing 5 of 5 · See all- K092306Securacath UniversalInterrad Medical, Inc. · 2010 · cites it directly4descendants
- K120935SecuracathInterrad Medical, Inc. · 2012 · 2 generations on3descendants
- K180769SecurAcathInterrad Medical, Inc. · 2018 · 3 generations on2descendants
- K180994SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath…Interrad Medical, Inc. · 2019 · 4 generations on1descendant
- K210629SecurAcathInterrad Medical, Inc. · 2021 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −7 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −6 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −5 | K034019 | Poly Per-Q-Cath Picc Catheters | C.R. Bard, Inc. | 2004 | 1 |
| −4 | K050931 | 6 FR DL Powerpicc Catheter | C.R. Bard, Inc. | 2005 | — |
| −3 | K051672 | Powerpicc | Bard Access Systems, Inc. | 2005 | 1 |
| −2 | K053501 | Powerpicc | Bard Access Systems, Inc. | 2006 | — |
| −1 | K082047 | Securacath Catheter, Model SPK01 | Interrad Medical, Inc. | 2008 | — |
| 0 (this device) | K083081 | Modification to Securacath, Model: SPK01 | Interrad Medical, Inc. | 2009 | — |
| +1 | K092306 | Securacath Universal | Interrad Medical, Inc. | 2010 | — |
| +2 | K120935 | Securacath | Interrad Medical, Inc. | 2012 | — |
| +3 | K180769 | SecurAcath | Interrad Medical, Inc. | 2018 | — |
| +4 | K180994 | SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F… | Interrad Medical, Inc. | 2019 | — |
| +5 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 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 OKC device
- #1 K210629 SecurAcathscore 4.8 · 13 generations · no Class I recall
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 |
|---|---|---|---|
| * | K082047 | Securacath Catheter, Model SPK01Summary page 2…injectors. 3.4 SUBSTANTIAL EQUIVALENCE The SecurAcath Catheter device covered by this submission is substantially equivalent to the Interrad Medical SecurAcath K082047 and Bard PowerPICC K051672 The SecurAcathTM has the same indication for use, same principles of operation, and similar tec… | 2008 |
| * | K051672 | PowerpiccSummary page 2…L EQUIVALENCE The SecurAcath Catheter device covered by this submission is substantially equivalent to the Interrad Medical SecurAcath K082047 and Bard PowerPICC K051672 The SecurAcathTM has the same indication for use, same principles of operation, and similar technological characteristics… | 2005 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092306 | Securacath Universal | 2010 | 4 |
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 · 4 generations back · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 12 months on median.
- 5 of the 16 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K092306 (Interrad Medical, Inc., 2010) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K082047.
How does its category compare?
All OKC devicesOKC Implanted Subcutaneous Securement Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 PICC is indicated for short or long term peripheral access to the central venous system. The catheter may be used for intravenous therapy, power injection of contrast media, and blood sampling and/or infusion therapy... The maximum recommended infusion rate is 5 ml/sec and the maximum pressure of power injectors may not exceed 300 psi. The SecurAcath PICC includes means to secure the catheter via a subcutaneous anchor below the insertion site.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083081 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083081: Modification to Securacath, Model: SPK01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083081
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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