FDA product code OWN: Confocal Optical Imaging
OWN is the FDA product code for confocal optical imaging. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the General and Plastic Surgery panel. FDA has cleared 62 510(k) submissions under OWN, 20 in the last five years, from 28 different applicants. The average 510(k) review took 132 days (median 90); 162 days on average over the last three years. FDA has posted 4 recalls for OWN devices, 4 initiated in the last five years.
Definition
Collection of light signals for visualization of cellular microstructures.
Classification
| Field | Value |
|---|---|
| Device name | Confocal Optical Imaging |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for OWN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 5 | 79 |
| 2018 | 1 | 29 |
| 2019 | 7 | 73 |
| 2020 | 7 | 113 |
| 2021 | 4 | 131 |
| 2022 | 4 | 114 |
| 2023 | 6 | 76 |
| 2024 | 1 | 105 |
| 2025 | 3 | 174 |
| 2026 | 6 | 207 |
Compare with all 510(k) review times · Search every OWN clearance
Top OWN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Mauna Kea Technologies | 15 | 2022-04-11 |
| Stryker | 6 | 2023-09-20 |
| Karl Storz SE & CO. KG | 4 | 2026-02-26 |
| Visionsense, Ltd. | 4 | 2022-10-28 |
| Novadaq Technologies Ulc. (Now A Part of Stryker) | 4 | 2020-11-05 |
23 more applicants have OWN clearances. See the full list in Caduvo.
Most recent OWN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254180 | LIMIS Development B.V. | PerfusiX-Imaging | 2026-07-24 | 213 |
| K242163 | SmartsurgN, Inc. | SmartSurgN Visualization System | 2026-04-20 | 635 |
| K254242 | Karl Storz SE & CO. KG | KARL STORZ ICG Imaging System with RUBINA® Lens | 2026-02-26 | 59 |
| K251852 | VPIX Medical, Inc. | cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200) | 2026-02-13 | 241 |
| K253972 | Karl Storz SE & CO. KG | IMAGE1 (TC400US); X-to-4U Adapter (TC040) | 2026-02-12 | 63 |
Recalls for OWN devices
4 product recalls in 2 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2024-09-24.
| Year | Recalls |
|---|---|
| 2022 | 3 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code OWN?
OWN is the FDA product code for confocal optical imaging. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the General and Plastic Surgery panel.
What device class is OWN?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code OWN?
Across 62 cleared submissions the average was 132 days from receipt to decision (median 90).
Which companies have the most OWN clearances?
Mauna Kea Technologies (15); Stryker (6); Karl Storz SE & CO. KG (4); Visionsense, Ltd. (4); Novadaq Technologies Ulc. (Now A Part of Stryker) (4).
Have OWN devices been recalled?
Yes: 4 product recalls across 2 recall events; the most recent began 2024-09-24.
Next steps
- Run an FDA pathway report with predicate devices for product code OWN
- Run a recall and safety report across every OWN manufacturer
- Watch product code OWN 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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