FDA product code OKC: Implanted Subcutaneous Securement Catheter
OKC is the FDA product code for implanted subcutaneous securement catheter. It is a Class II device, regulated under 21 CFR 880.5970 and reviewed by the General Hospital panel. FDA has cleared 5 510(k) submissions under OKC. The average 510(k) review took 76 days (median 74). FDA has posted 1 recall for OKC devices, 1 initiated in the last five years.
Definition
Access to central venous system for blood sampling and infusion, and to provide a means to secure the catheter via a subcutaneous anchor below the insertion site.
Classification
| Field | Value |
|---|---|
| Device name | Implanted Subcutaneous Securement Catheter |
| Device class | Class II |
| Regulation | 21 CFR 880.5970 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for OKC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 95 |
| 2021 | 1 | 41 |
Top OKC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Interrad Medical, Inc. | 5 | 2021-04-12 |
Most recent OKC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K210629 | Interrad Medical, Inc. | SecurAcath | 2021-04-12 | 41 |
| K180769 | Interrad Medical, Inc. | SecurAcath | 2018-06-26 | 95 |
| K120935 | Interrad Medical, Inc. | SECURACATH | 2012-04-27 | 30 |
| K083081 | Interrad Medical, Inc. | MODIFICATION TO SECURACATH, MODEL: SPK01 | 2009-03-04 | 139 |
| K082047 | Interrad Medical, Inc. | SECURACATH CATHETER, MODEL SPK01 | 2008-09-30 | 74 |
Recalls for OKC devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-05-25.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code OKC?
OKC is the FDA product code for implanted subcutaneous securement catheter. It is a Class II device, regulated under 21 CFR 880.5970 and reviewed by the General Hospital panel.
What device class is OKC?
Class II, regulation 21 CFR 880.5970. Typical premarket route: 510(k).
How long does a 510(k) take for product code OKC?
Across 5 cleared submissions the average was 76 days from receipt to decision (median 74).
Which companies have the most OKC clearances?
Interrad Medical, Inc. (5).
Have OKC devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2022-05-25.
Next steps
- Run an FDA pathway report with predicate devices for product code OKC
- Run a recall and safety report across every OKC manufacturer
- Watch product code OKC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All General Hospital product codes · FDA product code lookup