FDA product code PSW: High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid
PSW is the FDA product code for high level disinfection reprocessing instrument for ultrasonic transducers, liquid. It is a Class II device, regulated under 21 CFR 892.1570 and reviewed by the General Hospital panel. FDA has cleared 7 510(k) submissions under PSW, 2 in the last five years, from 2 different applicants. The average 510(k) review took 164 days (median 179).
Definition
To provide high level disinfection of ultrasound transducers If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Classification
| Field | Value |
|---|---|
| Device name | High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid |
| Device class | Class II |
| Regulation | 21 CFR 892.1570 |
| Review panel | HO — General Hospital |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
510(k) clearances per year for PSW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 179 |
| 2020 | 1 | 229 |
| 2023 | 2 | 86 |
Compare with all 510(k) review times · Search every PSW clearance
Top PSW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cs Medical, LLC | 6 | 2023-11-21 |
| Pci Medical, Inc. | 1 | 2015-11-16 |
Most recent PSW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K233049 | Cs Medical, LLC | TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck Chemical Indicator | 2023-11-21 | 57 |
| K230381 | Cs Medical, LLC | Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical Indicator | 2023-06-07 | 114 |
| K192228 | Cs Medical, LLC | CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant | 2020-04-01 | 229 |
| K182891 | Cs Medical, LLC | TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants | 2019-04-12 | 179 |
| K160921 | Cs Medical, LLC | CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level Disinfectant, CS Medical TD-8 High Level Disinfectant | 2016-11-03 | 213 |
Recalls for PSW devices
openFDA lists no recalls for product code PSW.
Frequently asked questions
What is FDA product code PSW?
PSW is the FDA product code for high level disinfection reprocessing instrument for ultrasonic transducers, liquid. It is a Class II device, regulated under 21 CFR 892.1570 and reviewed by the General Hospital panel.
What device class is PSW?
Class II, regulation 21 CFR 892.1570. Typical premarket route: 510(k).
How long does a 510(k) take for product code PSW?
Across 7 cleared submissions the average was 164 days from receipt to decision (median 179).
Which companies have the most PSW clearances?
Cs Medical, LLC (6); Pci Medical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PSW
- Run a recall and safety report across every PSW manufacturer
- Watch product code PSW 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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