Kli: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Kli” (first 1977, latest 1980), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 12 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 |
|---|---|---|---|
| HET | Laparoscope, Gynecologic (And Accessories) | 9 | 9 |
| KNF | Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | 3 | 3 |
| HIF | Insufflator, Laparoscopic | 2 | 2 |
| HIN | Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) | 2 | 2 |
| FAP | Cystometric Gas (Carbon-Dioxide) On Hydraulic Device | 1 | 1 |
| FGC | Urethroscope | 1 | 1 |
Review panels
Most recent Kli 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K800822 | CO2 CYSTOSCOPY/URETHROSCOPY CONSOLE | FAP | 1980-06-17 | 64 |
| K800913 | GYNECOLOGICAL CYSTO/URETHROSCOPE | FGC | 1980-05-14 | 23 |
| K781913 | INSUFFALATOR LAPARAOSCOPIC | HIF | 1978-12-04 | 20 |
| K781109 | FORCEPS, ELECTROSURGICAL | HIN | 1978-09-14 | 76 |
| K781089 | ONE INCISION BI-POLAR ELECTRO. FORCEPS | HIN | 1978-07-17 | 18 |
| K780955 | SCISSORS, HOOK, ELECTROSURGICAL | KNF | 1978-06-22 | 13 |
| K780954 | SCISSORS, HOOK, ELECTROSURGICAL | KNF | 1978-06-22 | 13 |
| K772297 | INSUFFLATOR, MODEL G100 & 200 | HIF | 1978-01-05 | 23 |
| K772242 | LAPAROSCOPY CONSOLE MODEL VIII | HET | 1977-12-20 | 12 |
| K772220 | PROBE, COAGULATION ACCESSORY | KNF | 1977-12-13 | 8 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Kli.
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 Kli?
FDA lists 18 510(k) clearances under the applicant name “Kli” (first 1977, latest 1980), across 6 product codes in 2 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 Kli?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kli is 12 days.
Which FDA product codes appear under Kli?
The most frequent FDA product codes under this applicant name are HET (Laparoscope, Gynecologic (And Accessories), 9); KNF (Coagulator-Cutter, Endoscopic, Unipolar (And Accessories), 3); HIF (Insufflator, Laparoscopic, 2).
Next steps
- See all 18 Kli clearances with predicates and recalls
- Run predicate analysis for product code HET, Kli'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.