FDA product code KPA: Slide Stainer, Automated
KPA is the FDA product code for slide stainer, automated. It is a Class I device, regulated under 21 CFR 864.3800 and reviewed by the Pathology panel. FDA has cleared 21 510(k) submissions under KPA, from 15 different applicants. The average 510(k) review took 48 days (median 35). FDA has posted 30 recalls for KPA devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Slide Stainer, Automated |
| Device class | Class I |
| Regulation | 21 CFR 864.3800 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KPA clearance
Top KPA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Innovative Medical Systems, Inc. | 4 | 1988-04-27 |
| American Bionetics, Inc. | 2 | 1988-12-14 |
| Wescor, Inc. | 2 | 1988-05-13 |
| Shaban Mfg. Co. | 2 | 1985-02-27 |
| Tecan U.S., Ltd. | 1 | 1994-01-28 |
10 more applicants have KPA clearances. See the full list in Caduvo.
Most recent KPA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K933996 | Tecan U.S., Ltd. | PROFIBLOT | 1994-01-28 | 164 |
| K884258 | American Bionetics, Inc. | VERSABLOT | 1988-12-14 | 64 |
| K881592 | Wescor, Inc. | WESCOR MODEL 7300 AEROSPRAY GRAM STAINER | 1988-05-13 | 31 |
| K880745 | Innovative Medical Systems, Inc. | LX-100 SLIDE STAINER | 1988-04-27 | 63 |
| K874887 | American Bionetics, Inc. | WESBLOT PROCESSOR | 1988-03-24 | 114 |
Recalls for KPA devices
30 product recalls in 23 recall events; 3 initiated in the last five years and 5 still open. Most recent: 2024-04-02.
| Year | Recalls |
|---|---|
| 2018 | 3 |
| 2019 | 2 |
| 2020 | 2 |
| 2021 | 2 |
| 2022 | 2 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code KPA?
KPA is the FDA product code for slide stainer, automated. It is a Class I device, regulated under 21 CFR 864.3800 and reviewed by the Pathology panel.
What device class is KPA?
Class I, regulation 21 CFR 864.3800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KPA?
Across 21 cleared submissions the average was 48 days from receipt to decision (median 35).
Which companies have the most KPA clearances?
Innovative Medical Systems, Inc. (4); American Bionetics, Inc. (2); Wescor, Inc. (2); Shaban Mfg. Co. (2); Tecan U.S., Ltd. (1).
Have KPA devices been recalled?
Yes: 30 product recalls across 23 recall events; the most recent began 2024-04-02.
Next steps
- Run an FDA pathway report with predicate devices for product code KPA
- Run a recall and safety report across every KPA manufacturer
- Watch product code KPA 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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