Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Genadyne Biotechnologies, Inc. · Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
223 daysmedian FDA review time
406 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253429 | Genadyne ASTRA NPWT | Genadyne Biotechnologies, Inc. | 2026-03-12 | 162 | 0 |
| K243225 | Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow M | Genadyne Biotechnologies, Inc. | 2024-12-31 | 84 | 0 |
| K233614 | Genadyne DUO NPWT | Genadyne Biotechnologies, Inc. | 2024-12-23 | 406 | 0 |
| K221888 | Genadyne Hybrid Foam Dressings | Genadyne Biotechnologies, Inc. | 2023-06-12 | 348 | 0 |
| K221891 | UNO Negative Pressure Wound Therapy System | Genadyne Biotechnologies, Inc. | 2022-12-14 | 168 | 0 |
| K210107 | Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy Sys | Genadyne Biotechnologies, Inc. | 2022-06-01 | 502 | 0 |
| K180840 | UNO Negative Pressure Wound Therapy System | Genadyne Biotechnologies, Inc. | 2018-11-30 | 245 | 0 |
| K161599 | UNO Negative Pressure Wound Therapy System | Genadyne Biotechnologies, Inc. | 2017-04-06 | 301 | 0 |
| K143726 | XLR8 PLUS (XLR8+) | Genadyne Biotechnologies, Inc. | 2015-06-19 | 172 | 0 |
| K142646 | XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dress | Genadyne Biotechnologies, Inc. | 2015-04-30 | 225 | 0 |
| K143574 | Melodi Prime Breast Pump | Genadyne Biotechnologies, Inc. | 2015-04-21 | 125 | 0 |
| K141961 | GENADYNE SPIRO FOAM DRESSING KIT | Genadyne Biotechnologies, Inc. | 2015-03-26 | 251 | 0 |
| K141437 | XLR8 PLUS (XLR8+) | Genadyne Biotechnologies, Inc. | 2014-09-19 | 112 | 0 |
| K112856 | LUCINA-MELODI | Genadyne Biotechnologies, Inc. | 2012-05-10 | 223 | 0 |
| K102516 | LUCINA MODEL MELODI | Genadyne Biotechnologies, Inc. | 2011-08-11 | 343 | 0 |
| K092992 | A4-XLR8 FOAM DRESSING | Genadyne Biotechnologies, Inc. | 2010-06-29 | 274 | 0 |
| K090638 | GENADYNE A4-XLR8 WOUND VACUUM SYSTEM | Genadyne Biotechnologies, Inc. | 2009-04-29 | 50 | 0 |
| K082676 | GENADYNE A4 WOUND VACUUM SYSTEM | Genadyne Biotechnologies, Inc. | 2008-12-18 | 94 | 0 |
| K080745 | GENADYNE A4 POWERED SUCTION PUMP | Genadyne Biotechnologies, Inc. | 2008-07-30 | 135 | 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