Mckinley, Inc.: FDA clearances and approvals
Mckinley, Inc. has 7 FDA 510(k) clearances (first 1998, latest 2004), across 3 product codes in 1 review panel. Median 510(k) review time: 83 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 |
|---|---|---|---|
| FRN | Pump, Infusion | 3 | 3 |
| MEB | Pump, Infusion, Elastomeric | 3 | 3 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
Review panels
- General Hospital (7)
Most recent Mckinley, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K042228 | BEELINE MOTIV, PROPOLIS, PCA | FRN | 2004-11-08 | 83 |
| K033039 | MODIFICATION TO: ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KITS | MEB | 2003-10-07 | 8 |
| K032642 | BEELINE SYSTEM | FRN | 2003-09-23 | 27 |
| K991275 | WALKMED 300, WALKMED 350, WALKMED IC, WALKMED PCA, WALKMED PLUS | FRN | 1999-07-01 | 78 |
| K990461 | MCKINLEY SP DISPOSABLE INFUSION PUMP | MEB | 1999-06-30 | 138 |
| K982256 | OUTBOUND DISPOSABLE SYRINGE INFUSER OUTBOUND 2 DISPOSABLE PUMP | MEB | 1998-09-30 | 96 |
| K971844 | MCKINLEY OUTBOUND-2 SYSTEM | FPA | 1998-01-23 | 249 |
Recalls
openFDA lists no recalls under a recalling firm named Mckinley, 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 Mckinley, 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 Mckinley, Inc. have?
Mckinley, Inc. has 7 FDA 510(k) clearances (first 1998, latest 2004), across 3 product codes in 1 review panel.
How long does FDA take to clear Mckinley, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Mckinley, Inc.'s cleared 510(k)s is 83 days.
What devices does Mckinley, Inc. make?
Its most frequent FDA product codes are FRN (Pump, Infusion, 3); MEB (Pump, Infusion, Elastomeric, 3); FPA (Set, Administration, Intravascular, 1).
Has Mckinley, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Mckinley, Inc. Related entities may recall under other names.
Next steps
- See all 7 Mckinley, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FRN, Mckinley, 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.