FDA product code FQH: Lavage, Jet
FQH is the FDA product code for lavage, jet. It is a Class II device, regulated under 21 CFR 880.5475 and reviewed by the General Hospital panel. FDA has cleared 53 510(k) submissions under FQH, 9 in the last five years, from 40 different applicants. The average 510(k) review took 144 days (median 93); 108 days on average over the last three years. FDA has posted 29 recalls for FQH devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Lavage, Jet |
| Device class | Class II |
| Regulation | 21 CFR 880.5475 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
510(k) clearances per year for FQH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 3 | 122 |
| 2021 | 1 | 93 |
| 2022 | 4 | 176 |
| 2023 | 3 | 304 |
| 2026 | 2 | 108 |
Compare with all 510(k) review times · Search every FQH clearance
Top FQH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Irrimax Corporation | 4 | 2022-09-22 |
| Erbe USA, Inc. | 3 | 2007-10-31 |
| Hydrocision, Inc. | 3 | 2003-05-09 |
| Bd | 2 | 2026-02-20 |
| Next Science, LLC | 2 | 2020-01-23 |
35 more applicants have FQH clearances. See the full list in Caduvo.
Most recent FQH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253996 | Becton, Dickinson and Company (BD) | BD Surgiphor Antimicrobial Irrigation System (910110) | 2026-02-25 | 75 |
| K253445 | Bd | BD Surgiphor 1000 mL Antimicrobial Irrigation System (910120) | 2026-02-20 | 141 |
| K231023 | Erbe Elektromedizin GmbH | ERBEJET® 2 System | 2023-06-15 | 65 |
| K220759 | Armis Biopharma, Inc. | Armis VeriCyn Wound Wash | 2023-05-25 | 436 |
| K220964 | Smith & Nephew Medical Limited | VERSAJET Hydrosurgery System (III) | 2023-05-16 | 410 |
Recalls for FQH devices
29 product recalls in 12 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2024-03-19.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2019 | 2 |
| 2022 | 1 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code FQH?
FQH is the FDA product code for lavage, jet. It is a Class II device, regulated under 21 CFR 880.5475 and reviewed by the General Hospital panel.
What device class is FQH?
Class II, regulation 21 CFR 880.5475. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FQH?
Across 53 cleared submissions the average was 144 days from receipt to decision (median 93).
Which companies have the most FQH clearances?
Irrimax Corporation (4); Erbe USA, Inc. (3); Hydrocision, Inc. (3); Bd (2); Next Science, LLC (2).
Have FQH devices been recalled?
Yes: 29 product recalls across 12 recall events; the most recent began 2024-03-19.
Next steps
- Run an FDA pathway report with predicate devices for product code FQH
- Run a recall and safety report across every FQH manufacturer
- Watch product code FQH 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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