Spelna, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Spelna, Inc.” (first 1982, latest 1986), across 7 product codes in 3 review panels. Median 510(k) review time under this name: 147 days. 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ELC | Scaler, Ultrasonic | 4 | 4 |
| EIA | Unit, Operative Dental | 2 | 2 |
| DSH | Recorder, Magnetic Tape, Medical | 1 | 1 |
| EKZ | Unit, Electrosurgical, And Accessories, Dental | 1 | 1 |
| FLG | Cleaner, Ultrasonic, Medical Instrument | 1 | 1 |
| KOJ | Airbrush | 1 | 1 |
Plus 1 more product codes.
Review panels
- Dental (8)
- Cardiovascular (1)
- General Hospital (1)
Most recent Spelna, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K852525 | SATALEC PIEZOTEC | ELC | 1986-01-30 | 230 |
| K852527 | SATALEC SEPTOSONIC SC 80/SC 120 | FLG | 1986-01-03 | 203 |
| K852522 | SATALEC SERVOTOME | EKZ | 1985-12-27 | 196 |
| K853200 | 5X2 SATALEC CHIROPODY CASE | — | 1985-10-18 | 126 |
| K852524 | SATALEC SERVOTORQUE S2 SX2 | EIA | 1985-07-31 | 47 |
| K852521 | SATLEC PROPHY UNIT PU 3055 | KOJ | 1985-07-31 | 47 |
| K832674 | SATELEC PROPHY UNIT PU 2000S | ELC | 1984-03-16 | 220 |
| K832664 | SATELEC SUPRASSON PIEZOMATIC P2 | ELC | 1984-03-16 | 220 |
| K832673 | SATELEC PROPHY UNIT PU-2000 | EIA | 1983-10-19 | 71 |
| K832665 | SATELEC SUPRASSON SP 3055 | ELC | 1983-10-19 | 71 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Spelna, 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 Spelna, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Spelna, Inc.” (first 1982, latest 1986), across 7 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Spelna, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Spelna, Inc. is 147 days.
Which FDA product codes appear under Spelna, Inc.?
The most frequent FDA product codes under this applicant name are ELC (Scaler, Ultrasonic, 4); EIA (Unit, Operative Dental, 2); DSH (Recorder, Magnetic Tape, Medical, 1).
Next steps
- See all 11 Spelna, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ELC, Spelna, 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, 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.