Disetronic Medical Systems: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Disetronic Medical Systems” (first 1991, latest 2001), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 55 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Roche Diagnostics, based on public ownership records.
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 |
|---|---|---|---|
| FRN | Pump, Infusion | 6 | 6 |
| FMI | Needle, Hypodermic, Single Lumen | 4 | 4 |
| LZG | Pump, Infusion, Insulin | 4 | 4 |
| FMF | Syringe, Piston | 2 | 2 |
| FRW | Scale, Patient | 1 | 1 |
Review panels
- General Hospital (13)
- Clinical Chemistry (4)
Most recent Disetronic Medical Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K013782 | DISETRONIC PENFINE INSULIN INJECTION PEN NEEDLE | FMI | 2001-11-20 | 6 |
| K994186 | DISETRONIC D-TRON INSULIN INFUSION PUMP | LZG | 1999-12-30 | 20 |
| K994197 | DISENTRONIC PENFINE INJECTION PEN NEEDLE | FMI | 1999-12-29 | 16 |
| K993666 | DISETRONIC PEN P100 | FMF | 1999-11-22 | 21 |
| K991376 | DAHEDI INSULIN INFUSION PUMP | LZG | 1999-06-15 | 55 |
| K990259 | DISETRONIC MULTIFUSE INFUSION PUMP SYSTEM | FRN | 1999-02-12 | 16 |
| K982966 | DISETRONIC PEN | FMF | 1998-10-19 | 55 |
| K982399 | DISETRONIC PENFINE INJECTION PEN NEEDLE | FMI | 1998-08-06 | 27 |
| K973339 | DISETRONIC PENFINE INJECTION PEN NEEDLE | FMI | 1997-09-24 | 19 |
| K973044 | DISETRONIC H-TRON PLUS V 100 INSULIN INFUSION PUMP | LZG | 1997-09-15 | 31 |
7 earlier clearances. See the full list in Caduvo.
Recalls
33 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2009-04-30.
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 Disetronic Medical Systems (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
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.
- Disetronic Medical Systems AG (12 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Disetronic Medical Systems?
FDA lists 17 510(k) clearances under the applicant name “Disetronic Medical Systems” (first 1991, latest 2001), across 5 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 Disetronic Medical Systems?
The median time from FDA receipt to decision across 510(k)s cleared under the name Disetronic Medical Systems is 55 days.
Which FDA product codes appear under Disetronic Medical Systems?
The most frequent FDA product codes under this applicant name are FRN (Pump, Infusion, 6); FMI (Needle, Hypodermic, Single Lumen, 4); LZG (Pump, Infusion, Insulin, 4).
Next steps
- See all 17 Disetronic Medical Systems clearances with predicates and recalls
- Run predicate analysis for product code FRN, Disetronic Medical Systems'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.