Medical Designs, LLC: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Medical Designs, LLC” (first 2000, latest 2018), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 100 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 | 1 | 183 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 189 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 2 | 92 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Medical Designs, LLC took a median 92 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 93 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 3 | 3 |
| JXG | Shunt, Central Nervous System And Components | 2 | 2 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
| PEK | Spinous Process Plate | 1 | 1 |
Review panels
- Orthopedic (5)
- Neurology (2)
Most recent Medical Designs, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K182352 | SP-LINK System | PEK | 2018-11-21 | 84 |
| K181591 | Fixated Asfora BULLET CAGE® (FABC) | MAX | 2018-09-26 | 100 |
| K143688 | ASFORA ANTERIOR CERVICAL PLATE SYSTEM | KWQ | 2015-07-01 | 189 |
| K112648 | ASFORA BULLET CAGE | MAX | 2012-03-13 | 183 |
| K090048 | ASFORA BULLET CAGE SYSTEM | MAX | 2009-08-14 | 219 |
| K042359 | SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT (SEPS-CA), (SEPS-CAL), (SEPS-CAND),MODELS 11-0401 CA, 11-0401-CAL | JXG | 2004-11-17 | 78 |
| K002970 | SUBDURAL EVACUATING PORT SYSTEM, MODEL 11-9901 | JXG | 2000-12-12 | 81 |
Recalls
openFDA lists no recalls under a recalling firm named Medical Designs, LLC.
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.
- Medical Analysis Systems, Inc. (107 510(k)s)
- Medical Components, Inc. (63 510(k)s)
- Medical Advances, Inc. (57 510(k)s)
- Medical Diagnostic Technologies, Inc. (57 510(k)s)
- Medical Devices, Inc. (49 510(k)s)
- Medical Device Technologies, Inc. (46 510(k)s)
- Medical Specialties, Inc. (40 510(k)s)
- Medical Device Inspection Co., Inc. (30 510(k)s)
- Medical Engineering Corp. (28 510(k)s)
- Medical Data Electronics (27 510(k)s)
- Medical Graphics Corp. (25 510(k)s)
- Medical Innovations Corp. (24 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medical Designs, LLC?
FDA lists 7 510(k) clearances under the applicant name “Medical Designs, LLC” (first 2000, latest 2018), across 4 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 Medical Designs, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medical Designs, LLC is 100 days.
Which FDA product codes appear under Medical Designs, LLC?
The most frequent FDA product codes under this applicant name are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 3); JXG (Shunt, Central Nervous System And Components, 2); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 1).
Next steps
- See all 7 Medical Designs, LLC clearances with predicates and recalls
- Run predicate analysis for product code MAX, Medical Designs, LLC'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.