FDA product code MEG: Syringe, Antistick
MEG is the FDA product code for syringe, antistick. It is a Class II device, regulated under 21 CFR 880.5860 and reviewed by the General Hospital panel. FDA has cleared 162 510(k) submissions under MEG, 20 in the last five years, from 109 different applicants. The average 510(k) review took 169 days (median 126); 248 days on average over the last three years. FDA has posted 17 recalls for MEG devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Syringe, Antistick |
| Device class | Class II |
| Regulation | 21 CFR 880.5860 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MEG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 110 |
| 2018 | 1 | 175 |
| 2019 | 4 | 259 |
| 2020 | 3 | 304 |
| 2021 | 5 | 171 |
| 2022 | 13 | 242 |
| 2023 | 5 | 239 |
| 2025 | 1 | 267 |
| 2026 | 1 | 230 |
Compare with all 510(k) review times · Search every MEG clearance
Top MEG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Safety Syringes, Inc. | 7 | 2013-03-26 |
| Life-Shield Products, Inc. | 5 | 2007-08-08 |
| M.K. Meditech Co. , Ltd. | 5 | 2005-04-05 |
| Shantou Wealy Medical Instrument Co.,Ltd | 4 | 2022-11-23 |
| Biotop Technology Co., Ltd. | 4 | 2007-01-03 |
104 more applicants have MEG clearances. See the full list in Caduvo.
Most recent MEG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252098 | Methyl Co., Ltd. | PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED) | 2026-02-18 | 230 |
| K250847 | Vault Paragon Group, Inc. | VaporShield | 2025-12-12 | 267 |
| K230287 | Suzhou Savicred Biotechnology Co., Ltd. | SaviSafe Safety Device | 2023-11-21 | 292 |
| K231165 | Shina Med Corporation | Shina Syringe; Shina Safety Syringe | 2023-10-27 | 185 |
| K231907 | Medline Industries, LP | Medline Safety Insulin and TB Syringes | 2023-10-18 | 111 |
Recalls for MEG devices
17 product recalls in 11 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2024-09-25.
| Year | Recalls |
|---|---|
| 2021 | 1 |
| 2022 | 2 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code MEG?
MEG is the FDA product code for syringe, antistick. It is a Class II device, regulated under 21 CFR 880.5860 and reviewed by the General Hospital panel.
What device class is MEG?
Class II, regulation 21 CFR 880.5860. Typical premarket route: 510(k).
How long does a 510(k) take for product code MEG?
Across 162 cleared submissions the average was 169 days from receipt to decision (median 126).
Which companies have the most MEG clearances?
Safety Syringes, Inc. (7); Life-Shield Products, Inc. (5); M.K. Meditech Co. , Ltd. (5); Shantou Wealy Medical Instrument Co.,Ltd (4); Biotop Technology Co., Ltd. (4).
Have MEG devices been recalled?
Yes: 17 product recalls across 11 recall events; the most recent began 2024-09-25.
Next steps
- Run an FDA pathway report with predicate devices for product code MEG
- Run a recall and safety report across every MEG manufacturer
- Watch product code MEG 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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