# Apex Medical Corp.

- Location (FDA's records): Shi-Chih, Taipei Hsien, TW
- FDA decisions: 36 (1987–2022): 36 510(k) clearances
- Names in FDA's records: Apex Medical Corp. (30); Apex Medical, Inc. (6)
- Product codes: BZD (12), GZJ (8), CAF (3), IPF (3), GXY (2), FNM (1), GEA (1), JOW (1), KDQ (1), ILX (1), BTA (1), BTT (1)
- 510(k) review time since 2016: median 255 days, against 137 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 19 (10 its own); citations of its devices by later devices: 29 (10 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Respironics, Inc.: 4 (https://510kreport.com/company/respironics)
- Resmed, Ltd.: 3 (https://510kreport.com/company/resmed)
- Covidien: 1 (https://510kreport.com/company/covidien)
- Sunrise Medical Hhg, Inc.: 1 (https://510kreport.com/company/sunrise-medical-hhg)

## Firms that cite its devices most
- Everlife Medical Equipment Co., Ltd.: 7 (https://510kreport.com/company/everlife-medical-equipment)
- Wellell, Inc.: 2 (https://510kreport.com/company/wellell)
- Lorenz Biotech S.P.A.: 2 (https://510kreport.com/company/lorenz-biotech)
- Xanacare Technologies, LLC: 1 (https://510kreport.com/company/xanacare-technologies)
- Acare Technology Co., Ltd.: 1 (https://510kreport.com/company/acare-technology)
- Emsi: 1 (https://510kreport.com/company/emsi)
- Basba, Inc.: 1 (https://510kreport.com/company/basba)
- Breathe Technologies, Inc.: 1 (https://510kreport.com/company/breathe-technologies)

## Its most-cited devices
- K021755: Apex Medical Digital Tens TS1211, TS1212 (2002), cited by 6
- K083656: Apex Medical XT Auto Cpap 9S-005200 (2009), cited by 2
- K070609: Apex Medical XT1 Cpap, Model 9S-005 (2007), cited by 2
- K103174: Apex Medical Wizard Series Cpap Mask (2011), cited by 2
- K970429: Bioscope SD Tens, Arista SD Plus, AP-102080T (1997), cited by 2
- K990435: Bestneb Portable Aerosol Therapy Unit, AP-100100 (2000), cited by 1

## Recent decisions
- K213577: VenAir, Sequential Compression System (Jun 28, 2022)
- K193206: WiZARD 510 Nasal Mask (Oct 29, 2020)
- K182394: WiZARD 310/320 Series CPAP Mask (May 17, 2019)
- K150111: Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series (Sep 15, 2015)
- K141522: Apex Medical Corp. Ich Cpap with Pva 9S-007XXX Series (Oct 6, 2014)
- K121642: Wizard 230 Nasal Pilow Mask (Jun 6, 2013)
- K112079: Apex Medical XT Auto Cpap with Compliance Improvement Algorithm 9S-005720 (Dec 6, 2012)
- K120035: Apex Medical Ich Cpap Series (9S-007XXX) (May 16, 2012)

Source page: https://510kreport.com/company/apex-medical