FDA product code PER: Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
PER is the FDA product code for automated pipetting, diluting and specimen processing workstations for flow cytometric analysis. It is a Class I device, regulated under 21 CFR 862.2750 and reviewed by the Clinical Chemistry panel. FDA has cleared 3 510(k) submissions under PER, from 2 different applicants. The average 510(k) review took 92 days (median 87). FDA has posted 10 recalls for PER devices, 4 initiated in the last five years.
Definition
Flow cytometer specimen processors are automated or semi-automated workstations designed to be used alone or in combination with manual methods to pipette, dilute and process human specimens in preparation for flow cytometric analysis.
Classification
| Field | Value |
|---|---|
| Device name | Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis |
| Device class | Class I |
| Regulation | 21 CFR 862.2750 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every PER clearance
Top PER applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Becton, Dickinson & CO | 2 | 2013-08-02 |
| Beckman Coulter, Inc. | 1 | 2013-07-15 |
Most recent PER clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K131301 | Becton, Dickinson & CO | BD FACS SAMPLE PREP ASSISTANT III | 2013-08-02 | 87 |
| K130253 | Beckman Coulter, Inc. | TQ-PREP WORKSTATION, PREPPLUS 2 WORKSTATION | 2013-07-15 | 164 |
| K050191 | Becton, Dickinson & CO | MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWARE | 2005-02-22 | 26 |
Recalls for PER devices
10 product recalls in 7 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2025-12-23.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2019 | 3 |
| 2020 | 1 |
| 2024 | 1 |
| 2025 | 3 |
Frequently asked questions
What is FDA product code PER?
PER is the FDA product code for automated pipetting, diluting and specimen processing workstations for flow cytometric analysis. It is a Class I device, regulated under 21 CFR 862.2750 and reviewed by the Clinical Chemistry panel.
What device class is PER?
Class I, regulation 21 CFR 862.2750. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code PER?
Across 3 cleared submissions the average was 92 days from receipt to decision (median 87).
Which companies have the most PER clearances?
Becton, Dickinson & CO (2); Beckman Coulter, Inc. (1).
Have PER devices been recalled?
Yes: 10 product recalls across 7 recall events; the most recent began 2025-12-23.
Next steps
- Run an FDA pathway report with predicate devices for product code PER
- Run a recall and safety report across every PER manufacturer
- Watch product code PER 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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