Geneva Laboratories, Inc.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Geneva Laboratories, Inc.” (first 1981, latest 1988), across 10 product codes in 5 review panels. Median 510(k) review time under this name: 77 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | 2 | 2 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 2 | 2 |
| EFQ | Gauze/Sponge, Internal | 1 | 1 |
| FCE | Enema Kit | 1 | 1 |
| HED | Douche Apparatus, Vaginal, Therapeutic | 1 | 1 |
| HIB | Speculum, Vaginal, Nonmetal | 1 | 1 |
| KDD | Kit, Surgical Instrument, Disposable | 1 | 1 |
| KSB | Set, Transfer (Blood/Plasma) | 1 | 1 |
| MMK | Container, Sharps | 1 | 1 |
Plus 1 more product codes.
Review panels
- Gastroenterology and Urology (3)
- General Hospital (3)
- Obstetrics and Gynecology (2)
- General and Plastic Surgery (2)
- Hematology (1)
Most recent Geneva Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K881217 | GENT-L-KARE STERILE URINARY LEG BAG | KNX | 1988-07-29 | 129 |
| K881218 | GENT-L-KARE CLEANSING ENEMA SET | FCE | 1988-07-28 | 128 |
| K881213 | GENT-L-KARE STERILE URINARY DRAINAGE BAG CENTER | KNX | 1988-07-28 | 129 |
| K881216 | GENT-L-KARE VAGINAL IRRIGATION SET | HED | 1988-06-07 | 77 |
| K861308 | ACCUPAC CUSTOM PACK KERLIX SQUARES | EFQ | 1986-05-02 | 24 |
| K861219 | ACCUPAC CUSTOM SKIN SCRUB KIT | — | 1986-04-15 | 14 |
| K853265 | ACCUPAC CUSTOM OPERATING ROOM PROCEDURE-DK876543 | — | 1985-08-26 | 21 |
| K843206 | COOK COUNTY HOSPITAL DRESSING CHANGE SET | KDD | 1985-05-24 | 282 |
| K844255 | GENT-L-KARE STERILE I.V. START KIT | FPA | 1984-12-19 | 47 |
| K843090 | UNIVERSITY OF CHICAGO VASCULAR ANGIOGRAM | FPA | 1984-12-04 | 120 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Geneva Laboratories, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Geneva Laboratories, Inc.?
FDA lists 13 510(k) clearances under the applicant name “Geneva Laboratories, Inc.” (first 1981, latest 1988), across 10 product codes in 5 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 Geneva Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Geneva Laboratories, Inc. is 77 days.
Which FDA product codes appear under Geneva Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are FPA (Set, Administration, Intravascular, 2); KNX (Collector, Urine, (And Accessories) For Indwelling Catheter, 2); EFQ (Gauze/Sponge, Internal, 1).
Next steps
- See all 13 Geneva Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FPA, Geneva Laboratories, 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 (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.