Clinical Innovations, LLC: FDA clearances and approvals
Clinical Innovations, LLC has 18 FDA 510(k) clearances (first 1994, latest 2025), across 11 product codes in 4 review panels. Median 510(k) review time: 168 days. Since 2017 its median was 58 days, against 90 days for all cleared 510(k)s in the same product codes. openFDA lists 8 product recalls by a recalling firm named Clinical Innovations, LLC.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 2 | 236 |
| 2015 | 1 | 19 |
| 2016 | 1 | 29 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 58 |
| 2024 | 0 | — |
| 2025 | 2 | 154 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Clinical Innovations, LLC's cleared 510(k)s took a median 58 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HFN | Transducer, Pressure, Intrauterine | 4 | 4 |
| HDB | Extractor, Vacuum, Fetal | 2 | 2 |
| HGP | Electrode, Circular (Spiral), Scalp And Applicator | 2 | 2 |
| LKF | Cannula, Manipulator/Injector, Uterine | 2 | 2 |
| OQY | Intrauterine Tamponade Balloon | 2 | 2 |
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | 1 | 1 |
| HDP | Elevator, Uterine | 1 | 1 |
| HFM | Monitor, Uterine Contraction, External (For Use In Clinic) | 1 | 1 |
| HFX | Clamp, Circumcision | 1 | 1 |
| KLA | Monitor, Esophageal Motility, Anorectal Motility, And Tube | 1 | 1 |
Plus 1 more product codes.
Review panels
- Obstetrics and Gynecology (15)
- Clinical Chemistry (1)
- Gastroenterology and Urology (1)
- General and Plastic Surgery (1)
Most recent Clinical Innovations, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250298 | Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum Delivery System, OmniCup® with Traction Force Indicator (VAC-DUAL MT); Kiwi® Complete Vacuum Delivery System, OmniC Cup® for Cesarean Section (VAC-DUAL C); Kiwi® Complete Vacuum Delivery System, ProCup® (VAC-DUAL S) | HDB | 2025-10-08 | 250 |
| K250897 | Koala Intrauterine Pressure Catheter (IPC-5000E) | HFN | 2025-05-22 | 58 |
| K223900 | babyLance Safety Heelstick (BLM, BLN, BLP) | FMK | 2023-02-24 | 58 |
| K153591 | ebb Complete Tamponade System | OQY | 2016-01-14 | 29 |
| K150573 | ebb Complete Tamponade System | OQY | 2015-03-25 | 19 |
| K140163 | KOALA TOCO | HFM | 2014-05-29 | 127 |
| K131781 | CLEARVIEW TOTAL | LKF | 2014-05-28 | 345 |
| K110605 | ROM PLUS | NQM | 2011-11-23 | 266 |
| K061539 | GOMCO CIRCUMCISION CLAMP, MOGEN CLAMP, PLASTIBELL CIRCUMCISION DEVICE | HFX | 2007-09-20 | 472 |
| K030691 | FETAL SPIRAL ELECTRODE, MODEL FSE07000 | HGP | 2003-09-17 | 196 |
8 earlier clearances. See the full list in Caduvo.
Recalls
8 product recalls in 7 recall events; 1 initiated in the last five years. Most recent: 2026-03-09.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Clinical Innovations, LLC have?
Clinical Innovations, LLC has 18 FDA 510(k) clearances (first 1994, latest 2025), across 11 product codes in 4 review panels.
How long does FDA take to clear Clinical Innovations, LLC's 510(k)s?
The median time from FDA receipt to decision across Clinical Innovations, LLC's cleared 510(k)s is 168 days. Since 2017: 58 days, versus 90 days for all cleared 510(k)s in the same product codes.
What devices does Clinical Innovations, LLC make?
Its most frequent FDA product codes are HFN (Transducer, Pressure, Intrauterine, 4); HDB (Extractor, Vacuum, Fetal, 2); HGP (Electrode, Circular (Spiral), Scalp And Applicator, 2).
Has Clinical Innovations, LLC had device recalls?
openFDA lists 8 product recalls in 7 recall events by a recalling firm whose name matches Clinical Innovations, LLC; the most recent began 2026-03-09. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 18 Clinical Innovations, LLC clearances with predicates and recalls
- Run predicate analysis for product code HFN, Clinical Innovations, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.