Surgical Information Sciences, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Surgical Information Sciences, Inc.” (first 2017, latest 2024), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 56 days. Since 2017 the median was 56 days, against 131 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 |
|---|---|---|
| 2017 | 1 | 130 |
| 2018 | 0 | — |
| 2019 | 2 | 80 |
| 2020 | 0 | — |
| 2021 | 1 | 79 |
| 2022 | 1 | 53 |
| 2023 | 1 | 27 |
| 2024 | 1 | 56 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Surgical Information Sciences, Inc. took a median 56 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 131 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 4 | 4 |
| QIH | Automated Radiological Image Processing Software | 3 | 3 |
Review panels
- Radiology (7)
Most recent Surgical Information Sciences, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241083 | SIS System | QIH | 2024-06-14 | 56 |
| K230977 | SIS System | QIH | 2023-05-02 | 27 |
| K223032 | SIS System (Version 5.6.0) | QIH | 2022-11-21 | 53 |
| K210071 | SIS System (Version 5.1.0) | LLZ | 2021-03-31 | 79 |
| K192304 | SIS Software Version 3.6.0 | LLZ | 2019-09-13 | 21 |
| K183019 | SIS Software version 3.3.0 | LLZ | 2019-03-19 | 139 |
| K162830 | SIS Software | LLZ | 2017-02-14 | 130 |
Recalls
openFDA lists no recalls under a recalling firm named Surgical Information Sciences, 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.
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.
- Surgical Laser Technologies, Inc. (51 510(k)s)
- Surgical Specialties Corp (33 510(k)s)
- Surgical Technologies, Inc. (28 510(k)s)
- Surgical Navigation Technologies, Inc. (27 510(k)s)
- Surgical Instrument Service and Savings, Inc. (23 510(k)s)
- Surgical Dynamics, Inc. (12 510(k)s)
- Surgical Technology Laboratories, Inc. (12 510(k)s)
- Surgical Appliance Industries, Inc. (9 510(k)s)
- Surgical Instruments Service and Savings, Inc. (8 510(k)s)
- Surgical Theater, Inc. (8 510(k)s)
- Surgical Innovations Plc (7 510(k)s)
- Surgical Specialties Corp. Dba Angiotech (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Surgical Information Sciences, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Surgical Information Sciences, Inc.” (first 2017, latest 2024), across 2 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 Surgical Information Sciences, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Surgical Information Sciences, Inc. is 56 days. Since 2017: 56 days, versus 131 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Surgical Information Sciences, Inc.?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 4); QIH (Automated Radiological Image Processing Software, 3).
Next steps
- See all 7 Surgical Information Sciences, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Surgical Information Sciences, 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.