FDA product code IFP: Formalin, Neutral Buffered
IFP is the FDA product code for formalin, neutral buffered. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel. FDA has cleared 15 510(k) submissions under IFP, from 10 different applicants. The average 510(k) review took 30 days (median 28). FDA has posted 2 recalls for IFP devices.
Classification
| Field | Value |
|---|---|
| Device name | Formalin, Neutral Buffered |
| Device class | Class I |
| Regulation | 21 CFR 864.4010 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every IFP clearance
Top IFP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Surgipath Medical Industries, Inc. | 4 | 1985-08-28 |
| Anatech, Ltd. | 3 | 1987-08-06 |
| Donald L. Price, Ph.D. | 1 | 1989-01-10 |
| Medical Specialties, Inc. | 1 | 1987-06-15 |
| Reagent Laboratory, Inc. | 1 | 1984-10-01 |
5 more applicants have IFP clearances. See the full list in Caduvo.
Most recent IFP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K884755 | Donald L. Price, Ph.D. | CONSED FECAL CONCENTRATION SYSTEM | 1989-01-10 | 57 |
| K872663 | Anatech, Ltd. | DRY-FORM | 1987-08-06 | 29 |
| K872140 | Medical Specialties, Inc. | (MSI) PATH-SAVER | 1987-06-15 | 13 |
| K870852 | Anatech, Ltd. | NBF 10% NEUTRAL BUFFERED FORMALIN | 1987-03-31 | 28 |
| K853497 | Surgipath Medical Industries, Inc. | PREFILLED SPECIMEN JARS 10% NEUTRAL BUF-FORMALIN | 1985-08-28 | 8 |
Recalls for IFP devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-06-13.
Frequently asked questions
What is FDA product code IFP?
IFP is the FDA product code for formalin, neutral buffered. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel.
What device class is IFP?
Class I, regulation 21 CFR 864.4010. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IFP?
Across 15 cleared submissions the average was 30 days from receipt to decision (median 28).
Which companies have the most IFP clearances?
Surgipath Medical Industries, Inc. (4); Anatech, Ltd. (3); Donald L. Price, Ph.D. (1); Medical Specialties, Inc. (1); Reagent Laboratory, Inc. (1).
Have IFP devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2016-06-13.
Next steps
- Run an FDA pathway report with predicate devices for product code IFP
- Run a recall and safety report across every IFP manufacturer
- Watch product code IFP 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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