FDA product code MEA: Pump, Infusion, Pca
MEA is the FDA product code for pump, infusion, pca. It is a Class II device, regulated under 21 CFR 880.5725 and reviewed by the General Hospital panel. FDA has cleared 31 510(k) submissions under MEA, from 24 different applicants. The average 510(k) review took 162 days (median 97). FDA has posted 46 recalls for MEA devices, 7 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Pump, Infusion, Pca |
| 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 MEA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 267 |
Compare with all 510(k) review times · Search every MEA clearance
Top MEA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hospira, Inc. | 3 | 2016-04-08 |
| Baxter Healthcare Corp | 3 | 2005-07-15 |
| Alaris Medical Systems, Inc. | 2 | 2004-12-10 |
| Pharmacia Deltec, Inc. | 2 | 1995-02-21 |
| C.R. Bard, Inc. | 2 | 1992-08-03 |
19 more applicants have MEA clearances. See the full list in Caduvo.
Most recent MEA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K162165 | Summit Medical Products, Inc. | ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump | 2017-08-29 | 391 |
| K170982 | Smiths Medical Ads, Inc. | CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Administrator Medication Safety Software; CADD® Administration Sets; Wireless Communication Module (CM) | 2017-08-24 | 143 |
| K143612 | Hospira, Inc. | LifeCare PCA Infusion System | 2016-04-08 | 476 |
| K130394 | Smiths Medical Asd, Inc. | CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0 | 2013-12-09 | 297 |
| K092313 | B.Braun Medical, Inc. | PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM | 2009-11-04 | 97 |
Recalls for MEA devices
46 product recalls in 27 recall events; 7 initiated in the last five years and 6 still open. Most recent: 2025-04-10.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2022 | 1 |
| 2024 | 3 |
| 2025 | 3 |
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 MEA?
MEA is the FDA product code for pump, infusion, pca. It is a Class II device, regulated under 21 CFR 880.5725 and reviewed by the General Hospital panel.
What device class is MEA?
Class II, regulation 21 CFR 880.5725. Typical premarket route: 510(k).
How long does a 510(k) take for product code MEA?
Across 31 cleared submissions the average was 162 days from receipt to decision (median 97).
Which companies have the most MEA clearances?
Hospira, Inc. (3); Baxter Healthcare Corp (3); Alaris Medical Systems, Inc. (2); Pharmacia Deltec, Inc. (2); C.R. Bard, Inc. (2).
Have MEA devices been recalled?
Yes: 46 product recalls across 27 recall events; the most recent began 2025-04-10.
Next steps
- Run an FDA pathway report with predicate devices for product code MEA
- Run a recall and safety report across every MEA manufacturer
- Watch product code MEA 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.
All General Hospital product codes · FDA product code lookup · 510(k) database search · 510(k) review times