# Demetech Corp.

- Location (FDA's records): Miami Lakes, FL
- FDA decisions: 16 (2002–2020): 16 510(k) clearances
- Names in FDA's records: Demetech Corp. (10); Demetech Corporation (5); Demetech AB (1)
- Product codes: NEW (3), GAM (3), GAT (2), FXX (1), GAR (1), KGI (1), GAW (1), NBY (1), GAL (1), GAQ (1), GAP (1)
- 510(k) review time since 2016: median 118 days, against 113 for FDA's reviews in the same codes and years (2 of 5 faster)
- Predicates its devices cite: 29 (2 its own); citations of its devices by later devices: 20 (2 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
- ETHICON, Inc.: 6 (https://510kreport.com/company/ethicon)
- Gramsmed, LLC: 3 (https://510kreport.com/company/gramsmed)
- Lunar Corp.: 2 (https://510kreport.com/company/lunar)
- Cp Medical: 2 (https://510kreport.com/company/cp-medical)
- Riverpoint Medical: 2 (https://510kreport.com/company/riverpoint-medical)
- V&Q Manufacturing Corporation: 1 (https://510kreport.com/company/v-q-manufacturing)
- Osteometer Meditech A/S: 1 (https://510kreport.com/company/osteometer-meditech-a-s)
- Osteogenics Biomedical, Inc.: 1 (https://510kreport.com/company/osteogenics-biomedical)

## Firms that cite its devices most
- Zephyr Sleep Technologies: 1 (https://510kreport.com/company/zephyr-sleep-technologies)
- Tianjin Aoshang Outdoor Equipment Co., Ltd.: 1 (https://510kreport.com/company/tianjin-aoshang-outdoor-equipment)
- Zhuhai Herald Datanetics Limited.: 1 (https://510kreport.com/company/zhuhai-herald-datanetics)
- Texas Medplast, LLC: 1 (https://510kreport.com/company/texas-medplast)
- Lear Corporation: 1 (https://510kreport.com/company/lear)
- Xinxiang Kangbeier Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/xinxiang-kangbeier-medical-technology)
- String King Lacrosse, LLC: 1 (https://510kreport.com/company/string-king-lacrosse)
- Peters Surgical: 1 (https://510kreport.com/company/peters-surgical)

## Its most-cited devices
- K201479: DemeMASK (2020), cited by 13
- K181582: DemeTECH DemeDIOX absorbable surgical suture (2018), cited by 2
- K082097: Demetech Polydioxanone Synthetic Monofilament (Pdo) Absorbable Suture (2010), cited by 2
- K043330: Polypropilene Surgical Sutures (2005), cited by 1
- K130083: Demecaprone (Poliglecaprone 25) Synthetic Monofilament (PGCL) Absorbable Suture (2013), cited by 1
- K023030: Demetech Polyester Nonabsorbable Suture (2003), cited by 1

## Recent decisions
- K201479: DemeMASK (Jul 24, 2020)
- K191361: DemeDIOX Barbed Absorbable Surgical Suture (Nov 7, 2019)
- K190777: DemeTECH DemeFORCE Nonabsorbable Surgical Suture (Jul 31, 2019)
- K181578: DemeTECH PTFE Nonabsorbable Surgical Suture (Oct 11, 2018)
- K181582: DemeTECH DemeDIOX absorbable surgical suture (Aug 27, 2018)
- K141007: Demesteel (Stainless Steel) Non-Absorbable Suture (Sep 25, 2014)
- K123940: Demequicktm (Rapid Absorbable) Synthetic Surgical Suture (May 30, 2014)
- K130083: Demecaprone (Poliglecaprone 25) Synthetic Monofilament (PGCL) Absorbable Suture (Jul 17, 2013)

Source page: https://510kreport.com/company/demetech