FDA product code LEA: Preservative, Cytological
LEA is the FDA product code for preservative, cytological. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel. FDA has cleared 4 510(k) submissions under LEA, from 3 different applicants. The average 510(k) review took 34 days (median 28). FDA has posted 4 recalls for LEA devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Preservative, Cytological |
| 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 LEA clearance
Top LEA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Lerner Laboratories, Inc. | 2 | 1976-12-06 |
| Devetec, Inc. | 1 | 1987-09-29 |
| Surgipath Medical Industries, Inc. | 1 | 1977-05-20 |
Most recent LEA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K873594 | Devetec, Inc. | TIF FECAL TEST | 1987-09-29 | 25 |
| K770592 | Surgipath Medical Industries, Inc. | CYTOLOGY FIXATIVE | 1977-05-20 | 53 |
| K761001 | Lerner Laboratories, Inc. | PAP-TRAY II (CATALOG #C600-2) | 1976-12-06 | 28 |
| K761000 | Lerner Laboratories, Inc. | PAP-TRAY I (CATALOG #C600-1) | 1976-12-06 | 28 |
Recalls for LEA devices
4 product recalls in 3 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-12-12.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code LEA?
LEA is the FDA product code for preservative, cytological. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel.
What device class is LEA?
Class I, regulation 21 CFR 864.4010. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LEA?
Across 4 cleared submissions the average was 34 days from receipt to decision (median 28).
Which companies have the most LEA clearances?
Lerner Laboratories, Inc. (2); Devetec, Inc. (1); Surgipath Medical Industries, Inc. (1).
Have LEA devices been recalled?
Yes: 4 product recalls across 3 recall events; the most recent began 2025-12-12.
Next steps
- Run an FDA pathway report with predicate devices for product code LEA
- Run a recall and safety report across every LEA manufacturer
- Watch product code LEA 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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