FDA product code QJY: Infusion Pump, Drug Specific, Pharmacy-Filled
QJY is the FDA product code for infusion pump, drug specific, pharmacy-filled. It is a Class II device, regulated under 21 CFR 880.5725 and reviewed by the General Hospital panel. FDA has cleared 4 510(k) submissions under QJY, 2 in the last five years, from 3 different applicants. The average 510(k) review took 138 days (median 120); 81 days on average over the last three years.
Definition
A Pharmacy-Filled, Drug Specific Infusion System is a prescription device intended for delivery of a specific drug in accordance with the FDA approved labeling and may be filled at a location other than point of care.
Classification
| Field | Value |
|---|---|
| Device name | Infusion Pump, Drug Specific, Pharmacy-Filled |
| Device class | Class II |
| Regulation | 21 CFR 880.5725 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
510(k) clearances per year for QJY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 2 | 194 |
| 2024 | 2 | 81 |
Compare with all 510(k) review times · Search every QJY clearance
Top QJY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Deka Research and Development | 2 | 2024-06-12 |
| Deka Research & Development Corp. | 1 | 2024-11-27 |
| DEKA Research & Development | 1 | 2020-02-21 |
Most recent QJY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243354 | Deka Research & Development Corp. | Remunity System | 2024-11-27 | 29 |
| K240256 | Deka Research and Development | Remunity System | 2024-06-12 | 133 |
| K202690 | Deka Research and Development | Remunity Pump for Remodulin (treprostinil) Injection | 2020-12-30 | 106 |
| K191313 | DEKA Research & Development | Unity Subcutaneous Infusion System for Remodulin | 2020-02-21 | 282 |
Recalls for QJY devices
openFDA lists no recalls for product code QJY.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- A4220 — Refill kit for implantable infusion pump
Frequently asked questions
What is FDA product code QJY?
QJY is the FDA product code for infusion pump, drug specific, pharmacy-filled. It is a Class II device, regulated under 21 CFR 880.5725 and reviewed by the General Hospital panel.
What device class is QJY?
Class II, regulation 21 CFR 880.5725. Typical premarket route: 510(k).
How long does a 510(k) take for product code QJY?
Across 4 cleared submissions the average was 138 days from receipt to decision (median 120).
Which companies have the most QJY clearances?
Deka Research and Development (2); Deka Research & Development Corp. (1); DEKA Research & Development (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QJY
- Run a recall and safety report across every QJY manufacturer
- Watch product code QJY for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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