Spectrum Medical , Ltd.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Spectrum Medical , Ltd.” (first 2007, latest 2025), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 60 days. Since 2017 the median was 96 days, against 126 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 | 1 | 26 |
| 2018 | 4 | 108 |
| 2019 | 1 | 102 |
| 2020 | 3 | 29 |
| 2021 | 1 | 60 |
| 2022 | 1 | 256 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 462 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Spectrum Medical , Ltd. took a median 96 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 126 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 7 | 7 |
| DTX | Gas Control Unit, Cardiopulmonary Bypass | 3 | 3 |
| DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | 2 | 2 |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 1 | 1 |
| DWA | Control, Pump Speed, Cardiopulmonary Bypass | 1 | 1 |
| DWC | Controller, Temperature, Cardiopulmonary Bypass | 1 | 1 |
Review panels
- Cardiovascular (15)
Most recent Spectrum Medical , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K240908 | Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM) | DTR | 2025-07-08 | 462 |
| K212657 | Quantum Heater-Cooler | DWC | 2022-05-06 | 256 |
| K210669 | Quantum Mini Ventilation Module | DTX | 2021-05-04 | 60 |
| K202733 | Quantum Ventilation Module | DTX | 2020-10-16 | 28 |
| K202557 | Quantum Workstation 12 Elite | DRY | 2020-10-02 | 29 |
| K192838 | Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure | DWA | 2020-04-13 | 193 |
| K190282 | Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) | DTQ | 2019-05-24 | 102 |
| K181942 | Quantum Ventilation Module | DTX | 2018-10-18 | 90 |
| K181923 | Quantum Workstation 12.1 | DRY | 2018-08-17 | 30 |
| K173834 | Quantum Pump Console | DTQ | 2018-05-25 | 158 |
5 earlier clearances. See the full list in Caduvo.
Recalls
4 product recalls in 3 recall events; 3 initiated in the last five years. Most recent: 2025-03-19.
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 Designs, Inc. (18 510(k)s)
- Spectrum X-Ray Corp. (9 510(k)s)
- Spectrum Dynamics Medical, Ltd. (8 510(k)s)
- Spectrum Medical S.R.L. (6 510(k)s)
- Spectrum Vascular (6 510(k)s)
- Spectrum Spine, Inc. (4 510(k)s)
- Spectrum Spine, LLC (4 510(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)
Frequently asked questions
How many FDA 510(k) clearances are listed under Spectrum Medical , Ltd.?
FDA lists 15 510(k) clearances under the applicant name “Spectrum Medical , Ltd.” (first 2007, latest 2025), across 6 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 Medical , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Spectrum Medical , Ltd. is 60 days. Since 2017: 96 days, versus 126 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Spectrum Medical , Ltd.?
The most frequent FDA product codes under this applicant name are DRY (Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass, 7); DTX (Gas Control Unit, Cardiopulmonary Bypass, 3); DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass, 2).
Next steps
- See all 15 Spectrum Medical , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DRY, Spectrum Medical , Ltd.'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.