Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Apex Medical Corp. — Predicate Candidate Screening
30 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
133 daysmedian FDA review time
480 days90th percentile
30clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K213577 | VenAir, Sequential Compression System | Apex Medical Corp. | 2022-06-28 | 230 | 0 |
| K193206 | WiZARD 510 Nasal Mask | Apex Medical Corp. | 2020-10-29 | 344 | 0 |
| K182394 | WiZARD 310/320 Series CPAP Mask | Apex Medical Corp. | 2019-05-17 | 255 | 0 |
| K150111 | Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series | Apex Medical Corp. | 2015-09-15 | 238 | 0 |
| K141522 | APEX MEDICAL CORP. ICH CPAP WITH PVA 9S-007XXX SERIES | Apex Medical Corp. | 2014-10-06 | 119 | 0 |
| K121642 | WIZARD 230 NASAL PILOW MASK | Apex Medical Corp. | 2013-06-06 | 367 | 0 |
| K112079 | APEX MEDICAL XT AUTO CPAP WITH COMPLIANCE IMPROVEMENT ALGORI | Apex Medical Corp. | 2012-12-06 | 504 | 0 |
| K120035 | APEX MEDICAL ICH CPAP SERIES (9S-007XXX) | Apex Medical Corp. | 2012-05-16 | 133 | 0 |
| K103174 | APEX MEDICAL WIZARD SERIES CPAP MASK | Apex Medical Corp. | 2011-05-06 | 191 | 0 |
| K103535 | VACPLUS SUCTION UNIT | Apex Medical Corp. | 2011-02-24 | 85 | 0 |
| K083656 | APEX MEDICAL XT AUTO CPAP 9S-005200 | Apex Medical Corp. | 2009-04-22 | 133 | 0 |
| K070990 | APEX MEDICAL MOBINEB, 9R-027 SERIES | Apex Medical Corp. | 2007-05-18 | 39 | 0 |
| K070609 | APEX MEDICAL XT1 CPAP, MODEL 9S-005 | Apex Medical Corp. | 2007-05-04 | 60 | 0 |
| K062664 | HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004 | Apex Medical Corp. | 2006-12-06 | 90 | 0 |
| K050104 | APEX MEDICAL MININEB & MINIPLUS | Apex Medical Corp. | 2005-02-16 | 29 | 0 |
| K041828 | APEX MEDICAL CPAP MODEL 9S-003 | Apex Medical Corp. | 2004-07-30 | 23 | 0 |
| K022650 | APEX MEDICAL CPAP RT 21XX | Apex Medical Corp. | 2004-02-04 | 544 | 0 |
| K021754 | APEX MEDICAL DIGITAL EMS TS1311, TS1312 | Apex Medical Corp. | 2002-06-28 | 30 | 0 |
| K021755 | APEX MEDICAL DIGITAL TENS TS1211, TS1212 | Apex Medical Corp. | 2002-06-12 | 14 | 0 |
| K020032 | APEX MEDICAL MINI TENS | Apex Medical Corp. | 2002-01-31 | 27 | 0 |
| K013813 | MODIFICATION TO:APEX MEDICAL IF-4100 | Apex Medical Corp. | 2001-12-14 | 28 | 0 |
| K012643 | APEX MEDICAL LCD TENS-VII | Apex Medical Corp. | 2001-10-29 | 77 | 0 |
| K012140 | COM-PATCH | Apex Medical Corp. | 2001-10-05 | 87 | 0 |
| K002339 | AEMS V, EMS-1000, MODEL TS-140500 AND AEMS VI, EMS-1000 PLUS | Apex Medical Corp. | 2001-08-24 | 388 | 0 |
| K002336 | MS104A, NEWMINI II (EMS-II), MODEL AP-101050T AND MEDTRIM (E | Apex Medical Corp. | 2001-07-27 | 360 | 0 |
| K990435 | BESTNEB PORTABLE AEROSOL THERAPY UNIT, AP-100100 | Apex Medical Corp. | 2000-06-05 | 480 | 0 |
| K973978 | MICRO II MICROCURRENT TENS | Apex Medical Corp. | 1998-07-29 | 282 | 0 |
| K973979 | MULTI-STIM TENS, AP-101081T | Apex Medical Corp. | 1998-07-29 | 282 | 0 |
| K973980 | ACU-STIM TENS, AP-101082T | Apex Medical Corp. | 1998-07-29 | 282 | 0 |
| K970429 | BIOSCOPE SD TENS, ARISTA SD PLUS, AP-102080T | Apex Medical Corp. | 1997-04-29 | 84 | 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