Medline: FDA clearances and approvals
Medline has 11 FDA 510(k) clearances (first 1992, latest 2012), across 9 product codes in 5 review panels. Median 510(k) review time: 56 days. It files with the SEC as Medline Inc. (MDLN).
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 21 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 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 |
|---|---|---|---|
| FMQ | Restraint, Protective | 2 | 2 |
| GCJ | Laparoscope, General & Plastic Surgery | 2 | 2 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| FRG | Wrap, Sterilization | 1 | 1 |
| FYA | Gown, Surgical | 1 | 1 |
| HFX | Clamp, Circumcision | 1 | 1 |
| IOR | Wheelchair, Mechanical | 1 | 1 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 | 1 |
| LZA | Polymer Patient Examination Glove | 1 | 1 |
Review panels
- General Hospital (6)
- General and Plastic Surgery (2)
- Obstetrics and Gynecology (1)
- Physical Medicine (1)
- Radiology (1)
Most recent Medline 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K120156 | PUREIMAGE ULTRASOUND TRANSMISSION GEL | ITX | 2012-02-08 | 21 |
| K051378 | POWDER-FREE BLUE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) | LZA | 2005-08-03 | 69 |
| K010825 | MEDLINE STERISET STERILIZATION CONTAINER | FRG | 2001-05-08 | 50 |
| K990463 | MEDLINE EXCEL WHEELCHAIRS | IOR | 1999-03-15 | 31 |
| K970282 | MEDLINE CIRCUMCISION TRAY | HFX | 1997-03-06 | 41 |
| K963504 | MEDLINE OPEN END FINGER CONTROL MITT | FMQ | 1996-10-29 | 56 |
| K963452 | MEDLINE ZIPPER SLEEVED VEST | FMQ | 1996-10-18 | 45 |
| K951736 | LOCK-UP | FMI | 1995-07-05 | 83 |
| K932033 | LAPAROSCOPIC SURGERY INSTRUMENTS | GCJ | 1995-06-19 | 783 |
| K932060 | MARTIN COLD LIGHT FOUNTAIN | GCJ | 1994-03-30 | 335 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medline.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
SEC filings
Medline Inc. (MDLN): EDGAR filings, CIK 2046386. Matched by exact company name.
Frequently asked questions
How many FDA 510(k) clearances does Medline have?
Medline has 11 FDA 510(k) clearances (first 1992, latest 2012), across 9 product codes in 5 review panels.
How long does FDA take to clear Medline's 510(k)s?
The median time from FDA receipt to decision across Medline's cleared 510(k)s is 56 days.
What devices does Medline make?
Its most frequent FDA product codes are FMQ (Restraint, Protective, 2); GCJ (Laparoscope, General & Plastic Surgery, 2); FMI (Needle, Hypodermic, Single Lumen, 1).
Has Medline had device recalls?
openFDA lists no recalls under a recalling firm name matching Medline. Related entities may recall under other names.
Next steps
- See all 11 Medline clearances with predicates and recalls
- Run predicate analysis for product code FMQ, Medline's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.