Meridian Medical Systems, LLC: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Meridian Medical Systems, LLC” (first 1994, latest 2016), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 110 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 266 |
| 2013 | 0 | — |
| 2014 | 1 | 264 |
| 2015 | 1 | 81 |
| 2016 | 1 | 24 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 5 | 5 |
| BSJ | Mask, Gas, Anesthetic | 1 | 1 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 1 | 1 |
| IZL | System, X-Ray, Mobile | 1 | 1 |
Review panels
- Radiology (6)
- Anesthesiology (2)
Most recent Meridian Medical Systems, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K162687 | Paragon 2 | IZL | 2016-10-21 | 24 |
| K143232 | Universal Digital Interface 2W, UDI 2W | MQB | 2015-01-30 | 81 |
| K140251 | UNIVERSAL DIGITAL INTERFACE 2, UDI 2 | MQB | 2014-10-22 | 264 |
| K112527 | UNIVERSAL DIGITAL INTERFACE (UDI) 1717 | MQB | 2012-05-22 | 265 |
| K111305 | UNIVERSAL DIGITAL INTERFACE WIRELESS - UDI 1417W | MQB | 2012-01-31 | 267 |
| K103599 | UNIVERSAL DIGITAL INTERFACE (UDI) 1717 | MQB | 2011-04-27 | 140 |
| K945984 | MERIDIAN MEDICAL SYSTEMS MAPLESON D AND MODIFIED JACKSON REESE CIRCUITS | CAI | 1994-12-27 | 19 |
| K944157 | DISPOSABLE, PREFORMED FACE MASK | BSJ | 1994-10-03 | 38 |
Recalls
openFDA lists no recalls under a recalling firm named Meridian Medical Systems, LLC.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Meridian Diagnostics, Inc. (92 510(k)s)
- Meridian Bioscience, Inc. (37 510(k)s)
- Meridian Co., Ltd. (7 510(k)s)
- Meridian AG (6 510(k)s)
- Meridian Medical Technologies, Inc. (6 510(k)s)
- Meridian Bioscience Israel , Ltd. (3 510(k)s)
- Meridian Dynamics Biomedical, Inc. (1 510(k)s)
- Meridian Medical (1 510(k)s)
- Meridian Technique, Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Meridian Medical Systems, LLC?
FDA lists 8 510(k) clearances under the applicant name “Meridian Medical Systems, LLC” (first 1994, latest 2016), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Meridian Medical Systems, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Meridian Medical Systems, LLC is 110 days.
Which FDA product codes appear under Meridian Medical Systems, LLC?
The most frequent FDA product codes under this applicant name are MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager), 5); BSJ (Mask, Gas, Anesthetic, 1); CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece), 1).
Next steps
- See all 8 Meridian Medical Systems, LLC clearances with predicates and recalls
- Run predicate analysis for product code MQB, Meridian Medical Systems, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.