Lsi Solutions: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Lsi Solutions” (first 1997, latest 2024), plus 1 De Novo decision, across 9 product codes in 4 review panels. Median 510(k) review time under this name: 90 days. Since 2017 the median was 161 days, against 108 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 | 1 | 459 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 161 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 2 | 40 |
| 2021 | 1 | 294 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 484 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Lsi Solutions took a median 161 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 108 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 5 | 5 |
| GAS | Suture, Nonabsorbable, Synthetic, Polyester | 2 | 2 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 1 | 1 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | 1 | 1 |
| HEW | Culdoscope (And Accessories) | 1 | 1 |
| NBY | Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene | 1 | 1 |
| NEW | Suture, Surgical, Absorbable, Polydioxanone | 1 | 1 |
| ODC | Endoscope Channel Accessory | 1 | 1 |
| SBK | Artificial Chordae Tendineae Surgical Replacement System | 1 | 0 |
Review panels
- General and Plastic Surgery (11)
- Cardiovascular (1)
- Gastroenterology and Urology (1)
- Obstetrics and Gynecology (1)
Most recent Lsi Solutions 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K222783 | MD Mattress Suture Placement Device | GCJ | 2024-01-12 | 484 |
| K202551 | Cor-Knot Micro | GCJ | 2021-06-24 | 294 |
| K203120 | RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD SUTURE, 2-0 Polypropylene | GAS | 2020-11-24 | 39 |
| K203081 | RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture | GAS | 2020-11-24 | 42 |
| K163639 | LS-5 ePTFE Suture | NBY | 2017-06-02 | 161 |
| K111014 | LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES | HEW | 2012-07-13 | 459 |
| K100593 | SUTURE PLACEMENT DEVICE AND ACCESSORIES, FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES, LSI R SERIES SUTURE PLACEME | GAW | 2010-10-13 | 225 |
| K040232 | LSI SEW-RIGHT R SERIES SUTURE PLACEMENT DEVICE AND ACCESS PRODUCT SEW-RIGHT SR-5R, MODEL 020999 | GAT | 2004-03-01 | 28 |
| K031443 | LSI SOLUTIONS SUTURE QUICK LOAD PRODUCTS | NEW | 2003-06-18 | 43 |
| K024301 | LSI ENDOSCOPIC EXTERNAL ACCESSORY CHANNEL AND ACCESSORIES PRODUCT | ODC | 2003-03-24 | 90 |
3 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN230069 | De Novo | Artificial Chordae Tendineae Surgical Replacement System | 2024-06-11 |
Recalls
openFDA lists no recalls under a recalling firm named Lsi Solutions.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Lsi Solutions?
FDA lists 13 510(k) clearances under the applicant name “Lsi Solutions” (first 1997, latest 2024), plus 1 De Novo decision, across 9 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 Lsi Solutions?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lsi Solutions is 90 days. Since 2017: 161 days, versus 108 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Lsi Solutions?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 5); GAS (Suture, Nonabsorbable, Synthetic, Polyester, 2); GAT (Suture, Nonabsorbable, Synthetic, Polyethylene, 1).
Next steps
- See all 13 Lsi Solutions clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Lsi Solutions'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.