Splintek, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Splintek, Inc.” (first 2017, latest 2025), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 116 days. Since 2017 the median was 116 days, against 152 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 |
|---|---|---|
| 2017 | 1 | 116 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 161 |
| 2021 | 2 | 111 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 122 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Splintek, Inc. took a median 116 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 152 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OBR | Mouthguard, Over-The-Counter | 3 | 3 |
| LRK | Device, Anti-Snoring | 1 | 1 |
| MQC | Mouthguard, Prescription | 1 | 1 |
Review panels
- Dental (5)
Most recent Splintek, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250122 | SleepRight Snore Aid | LRK | 2025-05-19 | 122 |
| K212767 | SleepRight Select-Comfort Dental Guard | MQC | 2021-12-22 | 113 |
| K212706 | SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard | OBR | 2021-12-13 | 109 |
| K193577 | SleepRight ProRx Custom Dental Guard | OBR | 2020-06-01 | 161 |
| K172223 | SleepRight ProRx Custom Dental Guard | OBR | 2017-11-17 | 116 |
Recalls
openFDA lists no recalls under a recalling firm named Splintek, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Splintek, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Splintek, Inc.” (first 2017, latest 2025), across 3 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 Splintek, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Splintek, Inc. is 116 days. Since 2017: 116 days, versus 152 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Splintek, Inc.?
The most frequent FDA product codes under this applicant name are OBR (Mouthguard, Over-The-Counter, 3); LRK (Device, Anti-Snoring, 1); MQC (Mouthguard, Prescription, 1).
Next steps
- See all 5 Splintek, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OBR, Splintek, Inc.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.