FDA product code MEB: Pump, Infusion, Elastomeric
MEB is the FDA product code for pump, infusion, elastomeric. It is a Class II device, regulated under 21 CFR 880.5725 and reviewed by the General Hospital panel. FDA has cleared 88 510(k) submissions under MEB, 3 in the last five years, from 42 different applicants. The average 510(k) review took 118 days (median 88); 306 days on average over the last three years. FDA has posted 109 recalls for MEB devices.
Classification
| Field | Value |
|---|---|
| Device name | Pump, Infusion, Elastomeric |
| 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 MEB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 304 |
| 2024 | 2 | 160 |
| 2026 | 1 | 452 |
Compare with all 510(k) review times · Search every MEB clearance
Top MEB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| I-Flow Corp. | 16 | 2007-01-26 |
| Baxter Healthcare Corp | 7 | 2007-05-25 |
| Novacon Corp. | 6 | 1999-09-10 |
| Advanced Infusion, Inc. | 5 | 2008-02-19 |
| Breg, Inc. | 5 | 2002-04-04 |
37 more applicants have MEB clearances. See the full list in Caduvo.
Most recent MEB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250234 | Epic Medical Pte. , Ltd. | SMARTeZ Elastomeric Infusion Pump (RS series) | 2026-04-24 | 452 |
| K240624 | First Medical Source, LLC | InfuLife | 2024-11-05 | 245 |
| K242152 | Epic Medical Pte. , Ltd. | SMARTeZ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) | 2024-10-07 | 76 |
| K181360 | Halyard Health | ON-Q* Pump with Bolus | 2019-03-22 | 304 |
| K151650 | Epic Medical Pte. , Ltd. | SMARTez elastomeric infusion pump | 2016-04-04 | 291 |
Recalls for MEB devices
109 product recalls in 28 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-05-23.
| Year | Recalls |
|---|---|
| 2018 | 17 |
| 2019 | 1 |
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 MEB?
MEB is the FDA product code for pump, infusion, elastomeric. It is a Class II device, regulated under 21 CFR 880.5725 and reviewed by the General Hospital panel.
What device class is MEB?
Class II, regulation 21 CFR 880.5725. Typical premarket route: 510(k).
How long does a 510(k) take for product code MEB?
Across 88 cleared submissions the average was 118 days from receipt to decision (median 88).
Which companies have the most MEB clearances?
I-Flow Corp. (16); Baxter Healthcare Corp (7); Novacon Corp. (6); Advanced Infusion, Inc. (5); Breg, Inc. (5).
Have MEB devices been recalled?
Yes: 109 product recalls across 28 recall events; the most recent began 2019-05-23.
Next steps
- Run an FDA pathway report with predicate devices for product code MEB
- Run a recall and safety report across every MEB manufacturer
- Watch product code MEB 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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