Spectrum Designs, Inc.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Spectrum Designs, Inc.” (first 1994, latest 1999), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 72 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 |
|---|---|---|---|
| FWP | Prosthesis, Chin, Internal | 7 | 7 |
| LZK | Implant, Malar | 6 | 6 |
| MDA | Elastomer, Silicone, For Scar Management | 2 | 2 |
| MIB | Elastomer, Silicone Block | 2 | 2 |
| MIC | Implant, Muscle, Pectoralis | 1 | 1 |
Review panels
Most recent Spectrum Designs, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K992522 | SPECTRUM DESIGNS SPECTRAGEL | MDA | 1999-10-26 | 90 |
| K982688 | SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK | MIB | 1998-10-13 | 71 |
| K980463 | SPECTRUM DESIGNS CURVILINEAR CHIN IMPLANT | FWP | 1998-05-06 | 90 |
| K980462 | SPECTRUM DESIGNS ANATOMICAL CHIN IMPLANT | FWP | 1998-05-06 | 90 |
| K980446 | SPECTRUM DESIGNS ANTERIOR CHIN IMPLANT | FWP | 1998-05-06 | 90 |
| K980445 | SPECTRUM DESIGNS CONCAVE BACK CHIN IMPLANT | FWP | 1998-05-06 | 90 |
| K980444 | SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANT | FWP | 1998-05-06 | 90 |
| K980138 | SPECTRUM DESIGNS SYMMETRICAL CHIN IMPLANT | FWP | 1998-04-03 | 78 |
| K980461 | SPECTRUM DESIGNS CLEFT CHIN IMPLANT | FWP | 1998-03-04 | 27 |
| K980141 | SPECTRUM DESIGNS PROJECTION MALAR IMPLANT | LZK | 1998-03-03 | 47 |
8 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2007-07-24.
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.
- Spectrum Medical , Ltd. (15 510(k)s)
- Spectrum X-Ray Corp. (9 510(k)s)
- Spectrum Dynamics Medical, Ltd. (8 510(k)s)
- Spectrum Spine, LLC (8 510(k)s)
- Spectrum Medical S.R.L. (6 510(k)s)
- Spectrum Vascular (6 510(k)s)
- Spectrum Co. (3 510(k)s)
- Spectrum Diagnostic, Inc. (3 510(k)s)
- Spectrum Dynamics , Ltd. (3 510(k)s)
- Spectrum Medical Technologies, Inc. (3 510(k)s)
- Spectrum Medical, Llp (2 510(k)s)
- Spectrum Antimicrobials, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Spectrum Designs, Inc.?
FDA lists 18 510(k) clearances under the applicant name “Spectrum Designs, Inc.” (first 1994, latest 1999), 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 Spectrum Designs, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Spectrum Designs, Inc. is 72 days.
Which FDA product codes appear under Spectrum Designs, Inc.?
The most frequent FDA product codes under this applicant name are FWP (Prosthesis, Chin, Internal, 7); LZK (Implant, Malar, 6); MDA (Elastomer, Silicone, For Scar Management, 2).
Next steps
- See all 18 Spectrum Designs, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FWP, Spectrum Designs, 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.