Latex Ind., Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Latex Ind., Inc.” (first 1977, latest 1981), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 44 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 |
|---|---|---|---|
| FCM | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | 8 | 8 |
| KOD | Catheter, Urological | 3 | 3 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 2 | 2 |
| EYZ | System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile | 1 | 1 |
Review panels
Most recent Latex Ind., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K812058 | AKRON URINARY DRAINAGE BAT | KNX | 1981-07-31 | 10 |
| K810281 | UROLOGICAL CATHETERS | KOD | 1981-02-25 | 23 |
| K791674 | BLADDER RETENTION CATHETERIZATION TRAY | KOD | 1979-11-05 | 70 |
| K781751 | CATHETER, AKRON FOLEY TEFLON | KOD | 1979-01-22 | 98 |
| K781433 | AKRON MALE EXTERNAL CATHETER | KNX | 1978-11-03 | 74 |
| K772277 | BLADDER RETENTION-CATHETHERIZATIONTRAY | FCM | 1978-03-02 | 83 |
| K780268 | BLADDER CATH KIT W/OUT CATHETER | FCM | 1978-02-24 | 7 |
| K780267 | CATH TRAY W/OUT CATHETER | EYZ | 1978-02-24 | 7 |
| K772342 | ROBINSON KIT - 750014 & 750016 | FCM | 1978-02-24 | 64 |
| K772341 | BLADDER KIT - 734000 | FCM | 1978-02-24 | 64 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Latex Ind., 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.
- Latex Medical Devices, Inc. (3 510(k)s)
- Latex Products Co., Inc. (1 510(k)s)
- Latex Supply Products (Hp), Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Latex Ind., Inc.?
FDA lists 14 510(k) clearances under the applicant name “Latex Ind., Inc.” (first 1977, latest 1981), across 4 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 Latex Ind., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Latex Ind., Inc. is 44 days.
Which FDA product codes appear under Latex Ind., Inc.?
The most frequent FDA product codes under this applicant name are FCM (Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit), 8); KOD (Catheter, Urological, 3); KNX (Collector, Urine, (And Accessories) For Indwelling Catheter, 2).
Next steps
- See all 14 Latex Ind., Inc. clearances with predicates and recalls
- Run predicate analysis for product code FCM, Latex Ind., 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.