FDA product code KZH: Introducer, Syringe Needle
KZH is the FDA product code for introducer, syringe needle. It is a Class II device, regulated under 21 CFR 880.6920 and reviewed by the General Hospital panel. FDA has cleared 47 510(k) submissions under KZH, 2 in the last five years, from 37 different applicants. The average 510(k) review took 116 days (median 88); 54 days on average over the last three years. FDA has posted 10 recalls for KZH devices.
Classification
| Field | Value |
|---|---|
| Device name | Introducer, Syringe Needle |
| Device class | Class II |
| Regulation | 21 CFR 880.6920 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
510(k) clearances per year for KZH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 233 |
| 2022 | 1 | 364 |
| 2024 | 1 | 54 |
Compare with all 510(k) review times · Search every KZH clearance
Top KZH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Owen Mumford USA, Inc. | 4 | 2001-11-13 |
| Medtronic Minimed | 3 | 2016-09-22 |
| Scandinavian Health Limited | 2 | 2014-09-12 |
| Owen Mumford, Ltd. | 2 | 2012-10-15 |
| Shl Medical, USA | 2 | 2006-06-12 |
32 more applicants have KZH clearances. See the full list in Caduvo.
Most recent KZH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243232 | Synthon Hispania S.L. | GripMate | 2024-12-02 | 54 |
| K213429 | Emed Technologies Corporation | AccuSert Needle Inserter | 2022-10-20 | 364 |
| K163400 | Ypsomed AG | Orbit Inserter | 2017-07-26 | 233 |
| K160860 | Medtronic Minimed | MiniMed Quick-serter | 2016-09-22 | 177 |
| K141384 | Scandinavian Health Limited | WHISPERJECT AUTOINJECTOR | 2014-09-12 | 108 |
Recalls for KZH devices
10 product recalls in 7 recall events; 0 initiated in the last five years and 2 still open. Most recent: 2019-07-17.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2019 | 2 |
Frequently asked questions
What is FDA product code KZH?
KZH is the FDA product code for introducer, syringe needle. It is a Class II device, regulated under 21 CFR 880.6920 and reviewed by the General Hospital panel.
What device class is KZH?
Class II, regulation 21 CFR 880.6920. Typical premarket route: 510(k).
How long does a 510(k) take for product code KZH?
Across 47 cleared submissions the average was 116 days from receipt to decision (median 88).
Which companies have the most KZH clearances?
Owen Mumford USA, Inc. (4); Medtronic Minimed (3); Scandinavian Health Limited (2); Owen Mumford, Ltd. (2); Shl Medical, USA (2).
Have KZH devices been recalled?
Yes: 10 product recalls across 7 recall events; the most recent began 2019-07-17.
Next steps
- Run an FDA pathway report with predicate devices for product code KZH
- Run a recall and safety report across every KZH manufacturer
- Watch product code KZH 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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