FDA product code KYZ: Syringe, Irrigating (Non Dental)
KYZ is the FDA product code for syringe, irrigating (non dental). It is a Class I device, regulated under 21 CFR 880.6960 and reviewed by the General Hospital panel. FDA has cleared 41 510(k) submissions under KYZ, from 33 different applicants. The average 510(k) review took 106 days (median 77). FDA has posted 20 recalls for KYZ devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Syringe, Irrigating (Non Dental) |
| Device class | Class I |
| Regulation | 21 CFR 880.6960 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
510(k) clearances per year for KYZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 121 |
Compare with all 510(k) review times · Search every KYZ clearance
Top KYZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Micromedics, Inc. | 4 | 2011-03-15 |
| Shippert Medical Technologies Corp. | 2 | 2009-08-17 |
| Sub-Q, Inc. | 2 | 1999-08-23 |
| Contour Fabricators of Florida, Inc. | 2 | 1995-08-07 |
| Nusurg, Inc. | 2 | 1993-11-04 |
28 more applicants have KYZ clearances. See the full list in Caduvo.
Most recent KYZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K201877 | Safkan, Inc. | OtoSet- Ear Cleaning System | 2020-11-05 | 121 |
| K102563 | Micromedics, Inc. | SINGLE CANNULA EXTENDED APPLICATOR | 2011-03-15 | 189 |
| K092022 | Shippert Medical Technologies Corp. | TISSU TRANS HARVEST TUBING | 2009-08-17 | 42 |
| K050797 | Shippert Medical Technologies Corp. | TISSU-TRANS | 2005-07-13 | 106 |
| K991254 | Sub-Q, Inc. | QS DELIVERY SYSTEM | 1999-08-23 | 132 |
Recalls for KYZ devices
20 product recalls in 15 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2026-06-30.
| Year | Recalls |
|---|---|
| 2017 | 3 |
| 2018 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code KYZ?
KYZ is the FDA product code for syringe, irrigating (non dental). It is a Class I device, regulated under 21 CFR 880.6960 and reviewed by the General Hospital panel.
What device class is KYZ?
Class I, regulation 21 CFR 880.6960. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KYZ?
Across 41 cleared submissions the average was 106 days from receipt to decision (median 77).
Which companies have the most KYZ clearances?
Micromedics, Inc. (4); Shippert Medical Technologies Corp. (2); Sub-Q, Inc. (2); Contour Fabricators of Florida, Inc. (2); Nusurg, Inc. (2).
Have KYZ devices been recalled?
Yes: 20 product recalls across 15 recall events; the most recent began 2026-06-30.
Next steps
- Run an FDA pathway report with predicate devices for product code KYZ
- Run a recall and safety report across every KYZ manufacturer
- Watch product code KYZ 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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