Apex Medical, Inc.
Malvern, PA, US
APEX MEDICAL, INC. appears in FDA device records in Malvern, PA. FDA records list 36 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 36 510(k) clearances for Apex Medical, Inc. between 1987 and 2022. The busiest year on record is 2001, with 5. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1987 | 2 |
| 1988 | 1 |
| 1989 | 1 |
| 1991 | 1 |
| 1994 | 1 |
| 1997 | 1 |
| 1998 | 3 |
| 2000 | 1 |
| 2001 | 5 |
| 2002 | 3 |
| 2004 | 2 |
| 2005 | 1 |
| 2006 | 1 |
| 2007 | 2 |
| 2009 | 1 |
| 2011 | 2 |
| 2012 | 2 |
| 2013 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K213577 | VenAir, Sequential Compression System | JOW | Substantially Equivalent | |
| K193206 | WiZARD 510 Nasal Mask | BZD | Substantially Equivalent | |
| K182394 | WiZARD 310/320 Series CPAP Mask | BZD | Substantially Equivalent | |
| K150111 | Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series | BZD | Substantially Equivalent | |
| K141522 | APEX MEDICAL CORP. ICH CPAP WITH PVA 9S-007XXX SERIES | BZD | Substantially Equivalent | |
| K121642 | WIZARD 230 NASAL PILOW MASK | BZD | Substantially Equivalent | |
| K112079 | APEX MEDICAL XT AUTO CPAP WITH COMPLIANCE IMPROVEMENT ALGORITHM 9S-005720 | BZD | Substantially Equivalent | |
| K120035 | APEX MEDICAL ICH CPAP SERIES (9S-007XXX) | BZD | Substantially Equivalent | |
| K103174 | APEX MEDICAL WIZARD SERIES CPAP MASK | BZD | Substantially Equivalent | |
| K103535 | VACPLUS SUCTION UNIT | JCX | Substantially Equivalent | |
| K083656 | APEX MEDICAL XT AUTO CPAP 9S-005200 | BZD | Substantially Equivalent | |
| K070990 | APEX MEDICAL MOBINEB, 9R-027 SERIES | CAF | Substantially Equivalent | |
| K070609 | APEX MEDICAL XT1 CPAP, MODEL 9S-005 | BZD | Substantially Equivalent | |
| K062664 | HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004 | BTT | Substantially Equivalent | |
| K050104 | APEX MEDICAL MININEB & MINIPLUS | CAF | Substantially Equivalent | |
| K041828 | APEX MEDICAL CPAP MODEL 9S-003 | BZD | Substantially Equivalent | |
| K022650 | APEX MEDICAL CPAP RT 21XX | BZD | Substantially Equivalent | |
| K021754 | APEX MEDICAL DIGITAL EMS TS1311, TS1312 | IPF | Substantially Equivalent | |
| K021755 | APEX MEDICAL DIGITAL TENS TS1211, TS1212 | GZJ | Substantially Equivalent | |
| K020032 | APEX MEDICAL MINI TENS | GZJ | Substantially Equivalent | |
| K013813 | MODIFICATION TO:APEX MEDICAL IF-4100 | GXY | Substantially Equivalent | |
| K012643 | APEX MEDICAL LCD TENS-VII | GZJ | Substantially Equivalent | |
| K012140 | COM-PATCH | GXY | Substantially Equivalent | |
| K002339 | AEMS V, EMS-1000, MODEL TS-140500 AND AEMS VI, EMS-1000 PLUS, MODEL TS-140600 | IPF | Substantially Equivalent | |
| K002336 | MS104A, NEWMINI II (EMS-II), MODEL AP-101050T AND MEDTRIM (EMS-V), MODEL AP-102050T | IPF | Substantially Equivalent | |
| K990435 | BESTNEB PORTABLE AEROSOL THERAPY UNIT, AP-100100 | CAF | Substantially Equivalent | |
| K973980 | ACU-STIM TENS, AP-101082T | GZJ | Substantially Equivalent | |
| K973979 | MULTI-STIM TENS, AP-101081T | GZJ | Substantially Equivalent | |
| K973978 | MICRO II MICROCURRENT TENS | GZJ | Substantially Equivalent | |
| K970429 | BIOSCOPE SD TENS, ARISTA SD PLUS, AP-102080T | GZJ | Substantially Equivalent | |
| K933965 | APEX MEDICAL AIR PUMPS | FNM | Substantially Equivalent | |
| K902102 | COM-TENS: A NEUROSTIMULATOR | GZJ | Substantially Equivalent | |
| K882816 | PULSAR EM | ILX | Substantially Equivalent | |
| K882468 | ELIMINATOR AIR FILTER | KDQ | Substantially Equivalent | |
| K871570 | APEX ALPHA VACUUM PUMP | BTA | Substantially Equivalent | |
| K871384 | APEX SUCTION CURETTE | GEA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005583187 | 3005583187 | APEX MEDICAL, INC. | 105 Quaker Ln, Malvern, PA 19355 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JCXApparatus, Suction, Ward Use, Portable, Ac-Powered
- KDQBottle, Collection, Vacuum
- GEACannula, Surgical, General & Plastic Surgery
- ILXDiathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
- GXYElectrode, Cutaneous
- BTTHumidifier, Respiratory Gas, (Direct Patient Interface)
- GZXInstrument, Microsurgical
- FNMMattress, Air Flotation, Alternating Pressure
- CAFNebulizer (Direct Patient Interface)
- BTAPump, Portable, Aspiration (Manual Or Powered)
- JOWSleeve, Limb, Compressible
- IPFStimulator, Muscle, Powered
- GZJStimulator, Nerve, Transcutaneous, For Pain Relief
- BZDVentilator, Non-Continuous (Respirator)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain