Maddak, Inc.: FDA clearances and approvals
Maddak, Inc. has 51 FDA 510(k) clearances (first 1977, latest 1984), across 27 product codes in 4 review panels. Median 510(k) review time: 16 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 |
|---|---|---|---|
| ION | Exerciser, Non-Measuring | 7 | 7 |
| IPS | Cane | 4 | 4 |
| ILI | Sling, Arm | 3 | 3 |
| ILS | Adaptor, Hygiene | 3 | 3 |
| IKX | Aid, Transfer | 2 | 2 |
| ILH | Splint, Hand, And Components | 2 | 2 |
| INM | Chair, With Casters | 2 | 2 |
| IPR | Crutch | 2 | 2 |
| IQC | Wheelchair, Special Grade | 2 | 2 |
| ITJ | Walker, Mechanical | 2 | 2 |
Plus 17 more product codes.
Review panels
Most recent Maddak, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K841700 | WALK & ROLL | INM | 1984-05-11 | 18 |
| K841698 | HEAT PACK | IMA | 1984-05-10 | 17 |
| K841695 | CRAWLER | KNL | 1984-05-10 | 17 |
| K841697 | HYDRO-THERO PAD | IRT | 1984-05-09 | 16 |
| K841693 | STANDING FRAME | — | 1984-05-09 | 16 |
| K841692 | PRONE STANDER | — | 1984-05-09 | 16 |
| K841691 | SPLIT SEAT POSITIONING CHAIR | INN | 1984-05-09 | 16 |
| K834311 | NIGHT TRAINER | KPN | 1984-03-30 | 126 |
| K833870 | KNEE WALKER | ION | 1983-11-29 | 21 |
| K833177 | GLOSSECTOMY FEEDING SPOONS | ILC | 1983-10-31 | 42 |
41 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Maddak, Inc..
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 Maddak, Inc.'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 Maddak, Inc. have?
Maddak, Inc. has 51 FDA 510(k) clearances (first 1977, latest 1984), across 27 product codes in 4 review panels.
How long does FDA take to clear Maddak, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Maddak, Inc.'s cleared 510(k)s is 16 days.
What devices does Maddak, Inc. make?
Its most frequent FDA product codes are ION (Exerciser, Non-Measuring, 7); IPS (Cane, 4); ILI (Sling, Arm, 3).
Has Maddak, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Maddak, Inc. Related entities may recall under other names.
Next steps
- See all 51 Maddak, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ION, Maddak, Inc.'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.