FDA product code KMK: Device, Intravascular Catheter Securement
KMK is the FDA product code for device, intravascular catheter securement. It is a Class I device, regulated under 21 CFR 880.5210 and reviewed by the General Hospital panel. FDA has cleared 64 510(k) submissions under KMK, from 54 different applicants. The average 510(k) review took 103 days (median 79). FDA has posted 7 recalls for KMK devices.
Classification
| Field | Value |
|---|---|
| Device name | Device, Intravascular Catheter Securement |
| Device class | Class I |
| Regulation | 21 CFR 880.5210 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
510(k) clearances per year for KMK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 449 |
Compare with all 510(k) review times · Search every KMK clearance
Top KMK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Op-Co Medical Products , Ltd. | 3 | 1995-08-09 |
| Ansley Medical Products, Inc. | 3 | 1992-11-23 |
| Tnt Moborg Intl. , Ltd. | 2 | 1994-07-14 |
| K-Lok, Inc. | 2 | 1994-02-18 |
| Vitaphore Corp. | 2 | 1990-01-11 |
49 more applicants have KMK clearances. See the full list in Caduvo.
Most recent KMK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K180994 | Interrad Medical, Inc. | SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F | 2019-07-09 | 449 |
| K981860 | Paraworks Enterprise, Ltd. | A P HARNESS | 1999-06-03 | 372 |
| K963365 | Byrd Medical Devices, Inc. | MULTI-PURPOSE MEDICAL TUBE HOLDER | 1996-10-11 | 45 |
| K941098 | Op-Co Medical Products , Ltd. | SECURE-SITE | 1995-08-09 | 518 |
| K943147 | Venetec, Inc. | STATLOCK CV | 1994-09-29 | 91 |
Recalls for KMK devices
7 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-04-25.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code KMK?
KMK is the FDA product code for device, intravascular catheter securement. It is a Class I device, regulated under 21 CFR 880.5210 and reviewed by the General Hospital panel.
What device class is KMK?
Class I, regulation 21 CFR 880.5210. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KMK?
Across 64 cleared submissions the average was 103 days from receipt to decision (median 79).
Which companies have the most KMK clearances?
Op-Co Medical Products , Ltd. (3); Ansley Medical Products, Inc. (3); Tnt Moborg Intl. , Ltd. (2); K-Lok, Inc. (2); Vitaphore Corp. (2).
Have KMK devices been recalled?
Yes: 7 product recalls across 4 recall events; the most recent began 2017-04-25.
Next steps
- Run an FDA pathway report with predicate devices for product code KMK
- Run a recall and safety report across every KMK manufacturer
- Watch product code KMK 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.
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