Spintech, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Spintech, Inc.” (first 1992, latest 2022), across 6 product codes in 4 review panels. Median 510(k) review time under this name: 137 days. Since 2017 the median was 131 days, against 133 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 143 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 3 | 131 |
| 2022 | 1 | 28 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Spintech, Inc. took a median 131 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 133 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EJI | Syringe, Cartridge | 3 | 3 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 3 | 3 |
| FMF | Syringe, Piston | 2 | 2 |
| FXX | Mask, Surgical | 2 | 2 |
| EFB | Handpiece, Air-Powered, Dental | 1 | 1 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 1 | 1 |
Review panels
- Dental (4)
- General Hospital (4)
- Radiology (3)
- Orthopedic (1)
Most recent Spintech, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K223079 | Stage | LNH | 2022-10-28 | 28 |
| K212109 | Spin Care Disposable Protective Mask Level 3 | FXX | 2021-11-14 | 131 |
| K210843 | STAGE | LNH | 2021-06-29 | 99 |
| K201624 | Spin Care Disposable Protective Mask | FXX | 2021-03-18 | 276 |
| K173224 | SPIN-SWI | LNH | 2018-02-23 | 143 |
| K023722 | SAFETYWAND DISPOSABLE HANDPIECE | EJI | 2003-09-02 | 301 |
| K010692 | THE WAND PLUS COMPUTER CONTROLLED ANESTHETIC DELIVERY SYSTEM | FMF | 2001-06-29 | 113 |
| K992404 | THE WAND | FMF | 2000-06-06 | 323 |
| K992819 | WAND PLUS | EJI | 2000-05-11 | 265 |
| K961648 | THE WAND | EJI | 1996-07-05 | 67 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Spintech, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Spintech, Inc. (a text match, not an official crosswalk):
- C8903 — Magnetic resonance imaging with contrast, breast; unilateral (via LNH)
- C8906 — Magnetic resonance imaging with contrast, breast; bilateral (via LNH)
- C8905 — Magnetic resonance imaging without contrast followed by with contrast, breast; unilateral (via LNH)
- C8908 — Magnetic resonance imaging without contrast followed by with contrast, breast; bilateral (via LNH)
- C8900 — Magnetic resonance angiography with contrast, abdomen (via LNH)
Frequently asked questions
How many FDA 510(k) clearances are listed under Spintech, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Spintech, Inc.” (first 1992, latest 2022), across 6 product codes in 4 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 Spintech, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Spintech, Inc. is 137 days. Since 2017: 131 days, versus 133 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Spintech, Inc.?
The most frequent FDA product codes under this applicant name are EJI (Syringe, Cartridge, 3); LNH (System, Nuclear Magnetic Resonance Imaging, 3); FMF (Syringe, Piston, 2).
Next steps
- See all 12 Spintech, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EJI, Spintech, 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.