Frantz Medical Development, Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Frantz Medical Development, Ltd.” (first 1987, latest 1998), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 106 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 |
|---|---|---|---|
| LZH | Pump, Infusion, Enteral | 2 | 2 |
| DXR | Ballistocardiograph | 1 | 1 |
| FCL | Forceps, Biopsy, Non-Electric | 1 | 1 |
| GCT | Light Source, Endoscope, Xenon Arc | 1 | 1 |
Review panels
Most recent Frantz Medical Development, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K981541 | CLEARSTAR ENTERAL NUTRITION PUMP | LZH | 1998-08-13 | 106 |
| K905282 | ENDOSCOPIC ACCESSORY TO THE LIGHT SOURCE | GCT | 1991-03-19 | 116 |
| K873119 | FLEXIFLO COMPANION ENTERAL NUTRITION PUMP | LZH | 1987-11-05 | 87 |
| K871710 | BIOPSY FORCEPS | FCL | 1987-08-10 | 101 |
| K863508 | FRANTZ MEDICAL ELECTRODE | DXR | 1987-02-06 | 150 |
Recalls
openFDA lists no recalls under a recalling firm named Frantz Medical Development, Ltd..
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Frantz Medical Development, Ltd. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via LZH)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via LZH)
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.
- Frantz Imaging, Inc. (5 510(k)s)
- Frantz Design, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Frantz Medical Development, Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Frantz Medical Development, Ltd.” (first 1987, latest 1998), across 4 product codes in 3 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 Frantz Medical Development, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Frantz Medical Development, Ltd. is 106 days.
Which FDA product codes appear under Frantz Medical Development, Ltd.?
The most frequent FDA product codes under this applicant name are LZH (Pump, Infusion, Enteral, 2); DXR (Ballistocardiograph, 1); FCL (Forceps, Biopsy, Non-Electric, 1).
Next steps
- See all 5 Frantz Medical Development, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LZH, Frantz Medical Development, Ltd.'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.