Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medline Industries, Inc. · Predicate Candidate Screening
238 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
113 daysmedian FDA review time
278 days90th percentile
238clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| DEN210049 | Medline ART Skin Harvesting System | Medline Industries, Inc. | 2024-03-27 | 890 | 0 |
| K230559 | Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief | Medline Industries, Inc. | 2023-10-26 | 240 | 0 |
| K223100 | Hudson RCI AquaTherm III Plus External Adjustable Electronic | Medline Industries, Inc. | 2023-06-27 | 270 | 0 |
| K222665 | Medline UNITE® Ankle Fusion Plating System | Medline Industries, Inc. | 2023-01-25 | 141 | 0 |
| K213054 | Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Sy | Medline Industries, Inc. | 2022-12-09 | 443 | 0 |
| K212911 | Konig Mogen Clamp | Medline Industries, Inc. | 2022-11-18 | 431 | 0 |
| K220565 | Hudson RCI Triflo II Incentive Deep Breathing Exerciser | Medline Industries, Inc. | 2022-10-25 | 239 | 0 |
| K213481 | Medline General Surgery Tray | Medline Industries, Inc. | 2022-05-24 | 207 | 39 |
| K212093 | Medline Universal Grounding Pad | Medline Industries, Inc. | 2022-01-14 | 192 | 0 |
| K213068 | Medline Smoke Evacuation Shroud | Medline Industries, Inc. | 2022-01-03 | 102 | 0 |
| K211612 | Medline UNITE REFLEX Dynamic Discs | Medline Industries, Inc. | 2021-12-10 | 198 | 0 |
| K212258 | Medline Cardiovascular Procedure Kit | Medline Industries, Inc. | 2021-12-03 | 136 | 0 |
| K211931 | Medline Digital Thermometer Non-Lubricated Probe Sheath | Medline Industries, Inc. | 2021-09-20 | 90 | 0 |
| K203538 | SensiCare PI Ortho LT Surgical Glove (Tested for Use with Ch | Medline Industries, Inc. | 2021-08-02 | 242 | 0 |
| K211944 | Medline UNITE® Digital Fusion Screw System | Medline Industries, Inc. | 2021-07-22 | 29 | 0 |
| K203135 | Medline Vacu-line Suction Aspirator | Medline Industries, Inc. | 2021-05-04 | 197 | 0 |
| K210482 | Medline UNITE REFLEX Nitinol Staple System | Medline Industries, Inc. | 2021-04-22 | 62 | 0 |
| K202447 | Medline Orbis Surgical Gown | Medline Industries, Inc. | 2021-04-02 | 219 | 0 |
| K210526 | Medline Cautery Tip Cleaner | Medline Industries, Inc. | 2021-03-12 | 17 | 0 |
| K202668 | Signature Latex and Signature Latex Micro, Powder-Free, Surg | Medline Industries, Inc. | 2020-12-19 | 96 | 0 |
| K202449 | Signature Latex LT, Powder-Free, Surgical Glove, Tested for | Medline Industries, Inc. | 2020-11-18 | 84 | 0 |
| K202179 | Medline Glide-On 3G Vinyl Examination Gloves (Tested for use | Medline Industries, Inc. | 2020-10-26 | 83 | 0 |
| K200150 | Medline Powder-Free Orange Nitrile Patient Examination Glove | Medline Industries, Inc. | 2020-10-26 | 278 | 0 |
| K202285 | Medline ENfit OTC Feeding Syringe | Medline Industries, Inc. | 2020-10-09 | 58 | 0 |
| K201290 | Medline DeNovo 4Pro Electrical Stimulation Device | Medline Industries, Inc. | 2020-09-21 | 130 | 0 |
| K201829 | SensiCare PI Evolution Surgical Glove (Tested for Use with C | Medline Industries, Inc. | 2020-09-09 | 69 | 0 |
| K193666 | Powder-Free Blue Nitrile Examination Gloves (Tested for use | Medline Industries, Inc. | 2020-08-04 | 217 | 0 |
| K193217 | SensiCare PI and SensiCare PI Micro Surgical Gloves | Medline Industries, Inc. | 2020-04-06 | 137 | 0 |
| K192988 | Dermasure Green Sterile SyntheticPolychloroprene Powder-Free | Medline Industries, Inc. | 2020-04-01 | 159 | 0 |
| K191753 | Medline Sterile Powder-Free Nitrile Examination Gloves - Gre | Medline Industries, Inc. | 2020-03-17 | 260 | 0 |
| K191915 | SensiCare Sterile Power-Free Polymer Coated Polyisoprene Sug | Medline Industries, Inc. | 2020-03-06 | 233 | 0 |
| K192820 | SensiCare Neoprene Synthetic Polychloroprene Surgical Glove | Medline Industries, Inc. | 2020-02-28 | 150 | 0 |
| K192641 | Gemini Titan Sterilization Wrap | Medline Industries, Inc. | 2020-01-24 | 122 | 0 |
| K192985 | Medline Glide-On 3G Vinyl Examination Gloves | Medline Industries, Inc. | 2020-01-21 | 88 | 0 |
| K192315 | Medline Green Ambidextrous Power-Free Nitrile Examination Gl | Medline Industries, Inc. | 2020-01-10 | 137 | 0 |
| K192104 | Medline Sterile Power-Free Nitrile Examination Gloves - Blue | Medline Industries, Inc. | 2019-12-23 | 140 | 0 |
| K191759 | Medline Quick Switch Valve with ENFit Connector | Medline Industries, Inc. | 2019-12-04 | 156 | 0 |
| K191378 | 0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe | Medline Industries, Inc. | 2019-09-15 | 115 | 0 |
| K190950 | Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medl | Medline Industries, Inc. | 2019-07-04 | 84 | 2 |
| K183431 | Medline Digital Rectal Thermometer Sheath | Medline Industries, Inc. | 2019-06-14 | 185 | 0 |
| K183335 | Medline Poly-Cath Red Polymer Urethral Catheter | Medline Industries, Inc. | 2019-06-12 | 191 | 0 |
| K190643 | Medline Electrocautery Pencil | Medline Industries, Inc. | 2019-05-06 | 54 | 0 |
| K183577 | Medline Quick-Clear Wand | Medline Industries, Inc. | 2019-05-04 | 134 | 0 |
| K182172 | Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgi | Medline Industries, Inc. | 2019-04-24 | 257 | 1 |
| K190224 | Medline Burn and Wound Dressing (OTC) | Medline Industries, Inc. | 2019-03-08 | 31 | 0 |
| K181782 | Medline Reinforced Epidural Catheter | Medline Industries, Inc. | 2019-03-04 | 244 | 0 |
| K182812 | Medline Cautery Electrode (SILICONE) | Medline Industries, Inc. | 2018-12-12 | 70 | 0 |
| K181820 | Medline Unite Mini Plates and Screws | Medline Industries, Inc. | 2018-11-01 | 115 | 0 |
| K181726 | Medline Patient Cables and Lead Wires | Medline Industries, Inc. | 2018-09-20 | 83 | 0 |
| K173911 | Medline Burn and Wound Dressing | Medline Industries, Inc. | 2018-07-19 | 209 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda