Clariance: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Clariance” (first 2012, latest 2025), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 51 days. Since 2017 the median was 28 days, against 89 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 179 |
| 2013 | 2 | 199 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 371 |
| 2022 | 1 | 68 |
| 2023 | 0 | — |
| 2024 | 4 | 28 |
| 2025 | 1 | 26 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Clariance took a median 28 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 89 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 3 | 3 |
| NKB | Thoracolumbosacral Pedicle Screw System | 3 | 3 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 2 | 2 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 1 | 1 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 1 | 1 |
Review panels
- Orthopedic (10)
Most recent Clariance 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243904 | Elegance® Anterior Cervical plate | KWQ | 2025-01-14 | 26 |
| K243670 | Idys® LIF | MAX | 2024-12-31 | 34 |
| K241863 | Erisma® Lp Spinal Fixation System; Erisma® LP MIS | NKB | 2024-07-24 | 27 |
| K240872 | Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System | NKB | 2024-04-26 | 28 |
| K240715 | Idys® C ZP 3DTi | OVE | 2024-03-22 | 7 |
| K220182 | Aggeris-C | KWQ | 2022-03-30 | 68 |
| K200919 | Idys ALIF 3DTi | MAX | 2021-04-12 | 371 |
| K130853 | IDYS(TM) C | ODP | 2013-11-13 | 230 |
| K131178 | IDYS LIF CAGES | MAX | 2013-10-10 | 168 |
| K120469 | ERISMA-LP | NKB | 2012-08-13 | 179 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2019-07-01.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Clariance is the lead sponsor of 1 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT05170815: Clariance ErYs Registry (Recruiting, started 2022-01-17)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Clariance, Sas (11 510(k)s)
- Clariance, SA (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Clariance?
FDA lists 10 510(k) clearances under the applicant name “Clariance” (first 2012, latest 2025), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Clariance?
The median time from FDA receipt to decision across 510(k)s cleared under the name Clariance is 51 days. Since 2017: 28 days, versus 89 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Clariance?
The most frequent FDA product codes under this applicant name are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 3); NKB (Thoracolumbosacral Pedicle Screw System, 3); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 2).
Next steps
- See all 10 Clariance clearances with predicates and recalls
- Run predicate analysis for product code MAX, Clariance's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.