Disetronic Medical Systems AG: FDA clearances and approvals
Disetronic Medical Systems AG has 12 FDA 510(k) clearances (first 2000, latest 2010), across 4 product codes in 2 review panels. Median 510(k) review time: 48 days.
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 |
|---|---|---|---|
| LZG | Pump, Infusion, Insulin | 6 | 6 |
| FPA | Set, Administration, Intravascular | 3 | 3 |
| FRN | Pump, Infusion | 2 | 2 |
| KZH | Introducer, Syringe Needle | 1 | 1 |
Review panels
Most recent Disetronic Medical Systems AG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K100704 | ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICE | FRN | 2010-05-14 | 63 |
| K070189 | ACCU-CHEK ULTRAFLEX INFUSION SET | FPA | 2007-02-21 | 30 |
| K063146 | ACCU-CHEK LINKASSIST | KZH | 2006-11-27 | 42 |
| K060876 | ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001; ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWA | LZG | 2006-06-15 | 76 |
| K042887 | ACCU-CHEK SPIRIT | LZG | 2005-03-18 | 150 |
| K043000 | MODIFICATION TO D-TRONPLUS | LZG | 2004-12-01 | 30 |
| K033892 | ULTRAFLEX INFUSION SET | FPA | 2004-03-09 | 84 |
| K023471 | DISETRONIC H-TRONPLUS INSULIN INFUSION PUMP | LZG | 2002-10-29 | 14 |
| K022831 | MODIFICATION TO DISETRONIC D-TRONPLUS INSULIN INFUSION PUMP | LZG | 2002-09-11 | 16 |
| K021725 | DISETRONIC D-TRON INSULIN INFUSION PUMP | LZG | 2002-08-02 | 70 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Disetronic Medical Systems AG.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Disetronic Medical Systems AG's product codes (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)
Frequently asked questions
How many FDA 510(k) clearances does Disetronic Medical Systems AG have?
Disetronic Medical Systems AG has 12 FDA 510(k) clearances (first 2000, latest 2010), across 4 product codes in 2 review panels.
How long does FDA take to clear Disetronic Medical Systems AG's 510(k)s?
The median time from FDA receipt to decision across Disetronic Medical Systems AG's cleared 510(k)s is 48 days.
What devices does Disetronic Medical Systems AG make?
Its most frequent FDA product codes are LZG (Pump, Infusion, Insulin, 6); FPA (Set, Administration, Intravascular, 3); FRN (Pump, Infusion, 2).
Has Disetronic Medical Systems AG had device recalls?
openFDA lists no recalls under a recalling firm name matching Disetronic Medical Systems AG. Related entities may recall under other names.
Next steps
- See all 12 Disetronic Medical Systems AG clearances with predicates and recalls
- Run predicate analysis for product code LZG, Disetronic Medical Systems AG'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.