FDA product code FPK: Tubing, Fluid Delivery
FPK is the FDA product code for tubing, fluid delivery. It is a Class II device, regulated under 21 CFR 880.5440 and reviewed by the General Hospital panel. FDA has cleared 64 510(k) submissions under FPK, from 54 different applicants. The average 510(k) review took 83 days (median 61). FDA has posted 28 recalls for FPK devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Tubing, Fluid Delivery |
| Device class | Class II |
| Regulation | 21 CFR 880.5440 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every FPK clearance
Top FPK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Churchill Corp. | 3 | 1987-06-15 |
| Clinical Connections, Inc. | 3 | 1987-04-30 |
| Medtronic Minimed | 2 | 2005-11-29 |
| Medrad, Inc. | 2 | 2003-07-11 |
| Degania Silicone , Ltd. | 2 | 1995-11-06 |
49 more applicants have FPK clearances. See the full list in Caduvo.
Most recent FPK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K131517 | Medrad, Inc. / Bayer Medical Care, Inc. | MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING | 2013-08-02 | 66 |
| K063114 | Coeur, Inc. | DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES | 2007-02-09 | 121 |
| K063239 | Hospira, Inc. | LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526 | 2006-12-11 | 46 |
| K052431 | Medtronic Minimed | MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1 | 2005-11-29 | 84 |
| K041178 | E-Z-Em, Inc. | EMPOWER TRANSFER SET, (CAT. NO. 7725) | 2004-07-16 | 72 |
Recalls for FPK devices
28 product recalls in 7 recall events; 1 initiated in the last five years and 2 still open. Most recent: 2025-06-05.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code FPK?
FPK is the FDA product code for tubing, fluid delivery. It is a Class II device, regulated under 21 CFR 880.5440 and reviewed by the General Hospital panel.
What device class is FPK?
Class II, regulation 21 CFR 880.5440. Typical premarket route: 510(k).
How long does a 510(k) take for product code FPK?
Across 64 cleared submissions the average was 83 days from receipt to decision (median 61).
Which companies have the most FPK clearances?
Churchill Corp. (3); Clinical Connections, Inc. (3); Medtronic Minimed (2); Medrad, Inc. (2); Degania Silicone , Ltd. (2).
Have FPK devices been recalled?
Yes: 28 product recalls across 7 recall events; the most recent began 2025-06-05.
Next steps
- Run an FDA pathway report with predicate devices for product code FPK
- Run a recall and safety report across every FPK manufacturer
- Watch product code FPK 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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