Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Unimed Medical Supplies, Inc. · Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
129 daysmedian FDA review time
182 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253162 | Temperature probes (T2252-PG); Temperature probes (TCMA-AG); | Unimed Medical Supplies, Inc. | 2026-06-05 | 252 | 0 |
| K260931 | Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103- | Unimed Medical Supplies, Inc. | 2026-04-14 | 25 | 0 |
| K253964 | Disposable Neonatal NIBP Cuff (U1681S-C51N) | Unimed Medical Supplies, Inc. | 2026-01-09 | 29 | 0 |
| K251691 | Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed | Unimed Medical Supplies, Inc. | 2025-12-01 | 182 | 0 |
| K251696 | Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U4 | Unimed Medical Supplies, Inc. | 2025-12-01 | 182 | 0 |
| K251693 | Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed | Unimed Medical Supplies, Inc. | 2025-11-18 | 169 | 0 |
| K251695 | Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed | Unimed Medical Supplies, Inc. | 2025-11-18 | 169 | 0 |
| K250931 | Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-11 | Unimed Medical Supplies, Inc. | 2025-08-13 | 138 | 0 |
| K251045 | Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neon | Unimed Medical Supplies, Inc. | 2025-07-15 | 103 | 0 |
| K243086 | Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U | Unimed Medical Supplies, Inc. | 2025-02-20 | 143 | 0 |
| K242580 | Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed | Unimed Medical Supplies, Inc. | 2025-02-06 | 160 | 0 |
| K222213 | Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-1 | Unimed Medical Supplies, Inc. | 2022-12-19 | 147 | 0 |
| K210019 | Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mains | Unimed Medical Supplies, Inc. | 2021-03-04 | 59 | 0 |
| K142832 | Unimed Disposable and Reusable SPO2 Sensors | Unimed Medical Supplies, Inc. | 2015-02-06 | 129 | 0 |
| K142489 | Unimed Disposable ECG lead wires | Unimed Medical Supplies, Inc. | 2014-11-04 | 61 | 0 |
| K121427 | UNIMED TEMPERATURE PROBE | Unimed Medical Supplies, Inc. | 2012-05-29 | 15 | 0 |
| K120364 | UNIMED DISPOSABLE BLOOD PRESSURE CUFF | Unimed Medical Supplies, Inc. | 2012-05-04 | 88 | 0 |
| K112544 | UNIMED BLOOD PRESSURE CUFF | Unimed Medical Supplies, Inc. | 2011-11-22 | 82 | 0 |
| K082546 | REUSABLE OHMEDA (U410-02), DATEX (U410-09) COMPATABLE ADULT | Unimed Medical Supplies, Inc. | 2008-12-02 | 90 | 0 |
| K082959 | PATIENT MONITORING CABLES FOR ECG, EKG, SPO2 AND BLOOD PRESS | Unimed Medical Supplies, Inc. | 2008-10-10 | 7 | 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