Parker Hannifin Corp.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Parker Hannifin Corp.” (first 1983, latest 2024), across 8 product codes in 4 review panels. Median 510(k) review time under this name: 119 days. Since 2017 the median was 123 days, against 214 days for all cleared 510(k)s in the same product codes. 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 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 184 |
| 2017 | 2 | 200 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 237 |
| 2022 | 0 | — |
| 2023 | 1 | 110 |
| 2024 | 1 | 119 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Parker Hannifin Corp. took a median 123 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 214 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FRN | Pump, Infusion | 4 | 4 |
| BZR | Mixer, Breathing Gases, Anesthesia Inhalation | 2 | 2 |
| PHL | Powered Exoskeleton | 2 | 2 |
| CBN | Apparatus, Gas-Scavenging | 1 | 1 |
| FIR | Pump, Blood, Extra-Luminal | 1 | 1 |
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | 1 | 1 |
| HCA | Catheter, Ventricular | 1 | 1 |
| KXM | System Accessories, Extracorporeal | 1 | 1 |
Review panels
Most recent Parker Hannifin Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241465 | Midas Flowmeter; eAVS | BZR | 2024-09-19 | 119 |
| K223452 | Nitronox Scavenger Plus | CBN | 2023-03-05 | 110 |
| K202480 | Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50 | BZR | 2021-04-22 | 237 |
| K171334 | Indego | PHL | 2017-09-08 | 123 |
| K161731 | Cleveland Multiport Ventricular Catheter Set | HCA | 2017-03-27 | 277 |
| K152416 | Indego | PHL | 2016-02-26 | 184 |
| K897086 | PARKER AMBULATORY MEDICATION INFUSION PUMP 2004 | FRN | 1990-09-28 | 282 |
| K863532 | MODIFIED LABELING TO MODEL 2000 AMBULATORY INFUSER | FRN | 1987-01-14 | 127 |
| K834461 | INFUSION PUMP PRIMER | FRN | 1984-01-30 | 42 |
| K833723 | MODEL 2000 AMBULATORY MED. INFUSER | FRN | 1984-01-30 | 98 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Parker Hannifin Corp..
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.
Device clinical trials
An industry sponsor named Parker Hannifin Corp. is the lead sponsor of 3 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03054064: Evaluating the Indego Exoskeleton for Persons With Hemiplegia Due to CVA (Completed, started 2017-02-21)
- NCT02793635: Indego Exoskeleton After SCI (Completed, started 2016-06)
- NCT02202538: Indego® Exoskeleton; Assessing Mobility for Persons With Spinal Cord Injury (SCI). (Completed, started 2014-08)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Parker Hannifin Corp. (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)
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.
- Parker Laboratories, Inc. (30 510(k)s)
- Parker Treadmill Co., Inc. (2 510(k)s)
- Parker Medical Assoc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Parker Hannifin Corp.?
FDA lists 13 510(k) clearances under the applicant name “Parker Hannifin Corp.” (first 1983, latest 2024), across 8 product codes in 4 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 Parker Hannifin Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Parker Hannifin Corp. is 119 days. Since 2017: 123 days, versus 214 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Parker Hannifin Corp.?
The most frequent FDA product codes under this applicant name are FRN (Pump, Infusion, 4); BZR (Mixer, Breathing Gases, Anesthesia Inhalation, 2); PHL (Powered Exoskeleton, 2).
Next steps
- See all 13 Parker Hannifin Corp. clearances with predicates and recalls
- Run predicate analysis for product code FRN, Parker Hannifin Corp.'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.