Otto Bock Healthcare LP: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Otto Bock Healthcare LP” (first 2003, latest 2022), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 122 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 | 1 | 502 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 301 |
| 2022 | 1 | 209 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Otto Bock Healthcare LP took a median 255 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 126 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ITI | Wheelchair, Powered | 7 | 7 |
| IOR | Wheelchair, Mechanical | 5 | 5 |
| MVA | Orthosis, Cranial | 3 | 3 |
| GXY | Electrode, Cutaneous | 1 | 1 |
| IQI | Orthosis, Limb Brace | 1 | 1 |
Review panels
- Physical Medicine (13)
- Neurology (4)
Most recent Otto Bock Healthcare LP 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K213587 | MyCRO Band | MVA | 2022-06-09 | 209 |
| K201426 | MyCRO Band | MVA | 2021-03-26 | 301 |
| K113164 | DISCOVERY TMAX MANUAL WHEELCHAIR | IOR | 2013-03-11 | 502 |
| K111278 | Z10 WHEELCHAIR PUSH AND BRAKE ASSIST DEVICE | ITI | 2011-09-16 | 134 |
| K111045 | CENTRO FAMILY OF MANUAL WHEELCHAIRS | IOR | 2011-07-15 | 91 |
| K101524 | C2000 POWERED WHEELCHAIR | ITI | 2010-09-29 | 119 |
| K082314 | BRAVORACER PEDIATRIC MANUAL WHEELCHAIR | IOR | 2008-10-28 | 76 |
| K073512 | START JUNIOR | IOR | 2008-01-14 | 31 |
| K070318 | SKIPPI POWERED WHEELCHAIR FOR CHILDREN | ITI | 2007-05-11 | 98 |
| K052771 | SENSOR WALK | IQI | 2006-05-03 | 215 |
7 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2016-01-04.
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.
- Otto Bock Orthopedic Industry, Inc. (6 510(k)s)
- Otto Bock Healthcare Products GmbH (3 510(k)s)
- Otto Bock Austria (2 510(k)s)
- Otto Back Healthcare, LP (1 510(k)s)
- Otto Bock Orthopaedische Industrie, Kg. (1 510(k)s)
- Otto Bock Pur Life Science GmbH (1 510(k)s)
- Otto C. Watzka (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Otto Bock Healthcare LP?
FDA lists 17 510(k) clearances under the applicant name “Otto Bock Healthcare LP” (first 2003, latest 2022), 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 Otto Bock Healthcare LP?
The median time from FDA receipt to decision across 510(k)s cleared under the name Otto Bock Healthcare LP is 122 days.
Which FDA product codes appear under Otto Bock Healthcare LP?
The most frequent FDA product codes under this applicant name are ITI (Wheelchair, Powered, 7); IOR (Wheelchair, Mechanical, 5); MVA (Orthosis, Cranial, 3).
Next steps
- See all 17 Otto Bock Healthcare LP clearances with predicates and recalls
- Run predicate analysis for product code ITI, Otto Bock Healthcare LP'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.