FDA product code FIH: Pump, Infusion Or Syringe, Extra-Luminal
FIH is the FDA product code for pump, infusion or syringe, extra-luminal. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 5 510(k) submissions under FIH, from 5 different applicants. The average 510(k) review took 298 days (median 193).
Classification
| Field | Value |
|---|---|
| Device name | Pump, Infusion Or Syringe, Extra-Luminal |
| Device class | Class II |
| Regulation | 21 CFR 876.5820 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
Compare with all 510(k) review times · Search every FIH clearance
Top FIH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| E-Z-Em, Inc. | 1 | 1995-03-21 |
| Pharmacia Deltec, Inc. | 1 | 1994-04-28 |
| Infusion Technology Intl. | 1 | 1994-04-28 |
| L H M Ent., Inc. | 1 | 1990-02-15 |
| B&B Medical Assoc., Inc. | 1 | 1988-10-21 |
Most recent FIH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K932055 | E-Z-Em, Inc. | PERCUPUMP II | 1995-03-21 | 692 |
| K935461 | Infusion Technology Intl. | VECTOR AMBULATORY DRUG DELIVERY SYSTEM | 1994-04-28 | 167 |
| K931113 | Pharmacia Deltec, Inc. | CADD-TPN(TM) AMBULATORY INFUSION SYSTEM | 1994-04-28 | 420 |
| K900439 | L H M Ent., Inc. | SINGLE-USE, STERILE, PREFILLED SYRINGE, 60CC | 1990-02-15 | 17 |
| K881707 | B&B Medical Assoc., Inc. | INTROCULAR FLUID INJECTOR | 1988-10-21 | 193 |
Recalls for FIH devices
openFDA lists no recalls for product code FIH.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- A4220 — Refill kit for implantable infusion pump
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter)
Frequently asked questions
What is FDA product code FIH?
FIH is the FDA product code for pump, infusion or syringe, extra-luminal. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is FIH?
Class II, regulation 21 CFR 876.5820. Typical premarket route: 510(k).
How long does a 510(k) take for product code FIH?
Across 5 cleared submissions the average was 298 days from receipt to decision (median 193).
Which companies have the most FIH clearances?
E-Z-Em, Inc. (1); Pharmacia Deltec, Inc. (1); Infusion Technology Intl. (1); L H M Ent., Inc. (1); B&B Medical Assoc., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FIH
- Run a recall and safety report across every FIH manufacturer
- Watch product code FIH 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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