FDA product code KEO: Formulations, Paraffin, All
KEO is the FDA product code for formulations, paraffin, all. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel. FDA has cleared 11 510(k) submissions under KEO, from 9 different applicants. The average 510(k) review took 22 days (median 28). FDA has posted 3 recalls for KEO devices.
Classification
| Field | Value |
|---|---|
| Device name | Formulations, Paraffin, All |
| 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 KEO clearance
Top KEO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Surgipath Medical Industries, Inc. | 3 | 1986-04-11 |
| Stephens Scientific | 1 | 1989-06-22 |
| Richard-Allan Medical Ind., Inc. | 1 | 1986-06-17 |
| Erie Scientific Co. | 1 | 1986-06-13 |
| Sherwood Medical Co. | 1 | 1984-06-26 |
4 more applicants have KEO clearances. See the full list in Caduvo.
Most recent KEO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K893772 | Stephens Scientific | TISSUE EMBEDDING MEDIUM | 1989-06-22 | 31 |
| K862223 | Richard-Allan Medical Ind., Inc. | MICRO THIN* PARAFFIN | 1986-06-17 | 6 |
| K862141 | Erie Scientific Co. | HISTOLOGY PARAFFIN | 1986-06-13 | 9 |
| K861270 | Surgipath Medical Industries, Inc. | BLUE RIBBON PARAFFIN INFILTRATION/EMBEDDING MED. | 1986-04-11 | 7 |
| K842053 | Sherwood Medical Co. | PARAPLAST EXTRA TISSUE EMBEDDING MED. | 1984-06-26 | 35 |
Recalls for KEO devices
3 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-04-16.
Frequently asked questions
What is FDA product code KEO?
KEO is the FDA product code for formulations, paraffin, all. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel.
What device class is KEO?
Class I, regulation 21 CFR 864.4010. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KEO?
Across 11 cleared submissions the average was 22 days from receipt to decision (median 28).
Which companies have the most KEO clearances?
Surgipath Medical Industries, Inc. (3); Stephens Scientific (1); Richard-Allan Medical Ind., Inc. (1); Erie Scientific Co. (1); Sherwood Medical Co. (1).
Have KEO devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2014-04-16.
Next steps
- Run an FDA pathway report with predicate devices for product code KEO
- Run a recall and safety report across every KEO manufacturer
- Watch product code KEO 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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