Spectra Medical Devices, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Spectra Medical Devices, Inc.” (first 2008, latest 2017), across 5 product codes in 4 review panels. Median 510(k) review time under this name: 152 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 | 1 | 117 |
| 2016 | 1 | 290 |
| 2017 | 1 | 290 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Spectra Medical Devices, Inc. took a median 290 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 122 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 2 | 2 |
| FMF | Syringe, Piston | 2 | 2 |
| NGT | Saline, Vascular Access Flush | 2 | 2 |
| DYB | Introducer, Catheter | 1 | 1 |
| KNW | Instrument, Biopsy | 1 | 1 |
Review panels
Most recent Spectra Medical Devices, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K163292 | Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford | BSP | 2017-09-08 | 290 |
| K151069 | SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle | BSP | 2016-02-05 | 290 |
| K142791 | Spectra Soft Tissue Biopsy Needles | KNW | 2015-01-21 | 117 |
| K103740 | SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE | NGT | 2011-07-29 | 219 |
| K082689 | STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE | NGT | 2009-03-20 | 186 |
| K082580 | SPECTRA GUIDEWIRE INTRODUCER NEEDLE | DYB | 2008-12-08 | 94 |
| K082674 | SPECTRA-GLASS LOR (LOSS OF RESISTANCE SYRINGE, 5CC METAL L/S OR L/L TIP, SPECTRA-GLASS LOR (LOSS OF RESISTANCE) SYRINGE | FMF | 2008-11-28 | 74 |
| K081524 | SPECTRA-LOR, 10 ML PLASTIC LOSS OF RESISTANCE SYRINGE, L/S, SPECTRA-LOR, 10ML PLASTIC LOSS OF RESISTANCE SYRINGE L/L | FMF | 2008-07-29 | 57 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2026-07-06.
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.
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.
- Spectra, Inc. (1 510(k)s)
- Spectra Gases, Inc. (1 510(k)s)
- Spectra Science (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Spectra Medical Devices, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Spectra Medical Devices, Inc.” (first 2008, latest 2017), across 5 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 Spectra Medical Devices, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Spectra Medical Devices, Inc. is 152 days.
Which FDA product codes appear under Spectra Medical Devices, Inc.?
The most frequent FDA product codes under this applicant name are BSP (Needle, Conduction, Anesthetic (W/Wo Introducer), 2); FMF (Syringe, Piston, 2); NGT (Saline, Vascular Access Flush, 2).
Next steps
- See all 8 Spectra Medical Devices, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BSP, Spectra Medical Devices, 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.