FDA product code KEL: Adhesive, Albumin-Based
KEL is the FDA product code for adhesive, albumin-based. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel. FDA has cleared 2 510(k) submissions under KEL, from 2 different applicants. The average 510(k) review took 8 days (median 8).
Classification
| Field | Value |
|---|---|
| Device name | Adhesive, Albumin-Based |
| 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 KEL clearance
Top KEL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Alpha-Tec Systems, Inc. | 1 | 1989-01-10 |
| Stat Path | 1 | 1988-04-18 |
Most recent KEL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K890022 | Alpha-Tec Systems, Inc. | ATS MAYER'S ALBUMIN | 1989-01-10 | 6 |
| K881477 | Stat Path | HISTOGRIP & HISTOGRIP GOLD CONCENTRATE/PREDILUTED | 1988-04-18 | 11 |
Recalls for KEL devices
openFDA lists no recalls for product code KEL.
Frequently asked questions
What is FDA product code KEL?
KEL is the FDA product code for adhesive, albumin-based. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel.
What device class is KEL?
Class I, regulation 21 CFR 864.4010. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KEL?
Across 2 cleared submissions the average was 8 days from receipt to decision (median 8).
Which companies have the most KEL clearances?
Alpha-Tec Systems, Inc. (1); Stat Path (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KEL
- Run a recall and safety report across every KEL manufacturer
- Watch product code KEL 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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