FDA product code DQI: Withdrawal/Infusion Pump
DQI is the FDA product code for withdrawal/infusion pump. It is a Class II device, regulated under 21 CFR 870.1800 and reviewed by the General Hospital panel. FDA has cleared 9 510(k) submissions under DQI, from 8 different applicants. The average 510(k) review took 145 days (median 146).
Classification
| Field | Value |
|---|---|
| Device name | Withdrawal/Infusion Pump |
| Device class | Class II |
| Regulation | 21 CFR 870.1800 |
| Review panel | HO — General Hospital |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every DQI clearance
Top DQI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Baxter Healthcare Corp | 2 | 1991-01-30 |
| Karl Storz Endoscopy | 1 | 1996-10-25 |
| W.O.M. World of Medicine GmbH | 1 | 1994-04-21 |
| C.R. Bard, Inc. | 1 | 1992-12-08 |
| Leocor, Inc. | 1 | 1992-09-01 |
3 more applicants have DQI clearances. See the full list in Caduvo.
Most recent DQI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K960486 | Karl Storz Endoscopy | KSEA MODEL 383320 20 ANGIOMAT | 1996-10-25 | 266 |
| K935763 | W.O.M. World of Medicine GmbH | SURGIPUMP | 1994-04-21 | 146 |
| K922541 | C.R. Bard, Inc. | USCI SUPER 9 PTCA GUIDING CATHETER | 1992-12-08 | 193 |
| K924110 | Leocor, Inc. | LEOCOR CORFLO PUMP -- MODIFICATION | 1992-09-01 | 90 |
| K905189 | Baxter Healthcare Corp | BAXTER ANGIOSCOPY PUMP TUBING SET (MODEL NL) | 1991-01-30 | 72 |
Recalls for DQI devices
openFDA lists no recalls for product code DQI.
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
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement
Frequently asked questions
What is FDA product code DQI?
DQI is the FDA product code for withdrawal/infusion pump. It is a Class II device, regulated under 21 CFR 870.1800 and reviewed by the General Hospital panel.
What device class is DQI?
Class II, regulation 21 CFR 870.1800. Typical premarket route: 510(k).
How long does a 510(k) take for product code DQI?
Across 9 cleared submissions the average was 145 days from receipt to decision (median 146).
Which companies have the most DQI clearances?
Baxter Healthcare Corp (2); Karl Storz Endoscopy (1); W.O.M. World of Medicine GmbH (1); C.R. Bard, Inc. (1); Leocor, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DQI
- Run a recall and safety report across every DQI manufacturer
- Watch product code DQI 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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