# Oridion Medical 1987, Ltd.

- Location (FDA's records): Jerusalem, IL
- FDA decisions: 19 (2001–2020): 19 510(k) clearances
- Product codes: CCK (17), MSQ (1), DQA (1)
- 510(k) review time since 2016: median 249 days, against 261 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 27 (8 its own); citations of its devices by later devices: 22 (8 its own)
- Recalls linked to its devices: 35 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Salter Labs: 3 (https://510kreport.com/company/salter-labs)
- Oridion Medical, Ltd.: 3 (https://510kreport.com/company/oridion-medical)
- Meretek Diagnostics, Inc.: 2 (https://510kreport.com/company/meretek-diagnostics)
- Covidien: 2 (https://510kreport.com/company/covidien)
- United States Endoscopy Group, Inc.: 2 (https://510kreport.com/company/united-states-endoscopy-group)
- Gi Supply: 2 (https://510kreport.com/company/gi-supply)
- Oridion Capnography, Inc.: 1 (https://510kreport.com/company/oridion-capnography)
- Spegas Industries, Ltd.: 1 (https://510kreport.com/company/spegas-industries)

## Firms that cite its devices most
- Covidien: 3 (https://510kreport.com/company/covidien)
- Dispo-Med (Malaysia) Sdn Bhd: 2 (https://510kreport.com/company/dispo-med-malaysia-sdn-bhd)
- Westmed, Inc.: 1 (https://510kreport.com/company/westmed)
- Endure Industries, Inc.: 1 (https://510kreport.com/company/endure-industries)
- Nonin Medical, Inc.: 1 (https://510kreport.com/company/nonin-medical)
- Exalenz Bioscience, Ltd.: 1 (https://510kreport.com/company/exalenz-bioscience)
- Nihon Kohden Corporation: 1 (https://510kreport.com/company/nihon-kohden)
- Revolutionary Medical Devices, Inc.: 1 (https://510kreport.com/company/revolutionary-medical-devices)

## Its most-cited devices
- K010024: O2/CO2 Nasal Filterline (2001), cited by 4
- K011050: Microstream Oral Nasal Cannula Filterline (2001), cited by 3
- K024300: Microcap Plus/NPB-75 (2003), cited by 3
- K150272: Capnostream 35 Portable Respiratory Monitor (2015), cited by 3
- K112368: CAPNOSTREAM20P with AI/Odi (2012), cited by 2
- K011536: Microstream O2/CO2 Oral Nasal Filterline (2001), cited by 2

## Recent decisions
- K200594: Capnostream 35 Portable Respiratory Monitor (Apr 27, 2020)
- K181624: Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line (Mar 22, 2019)
- K181467: Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter Line (Feb 8, 2019)
- K150272: Capnostream 35 Portable Respiratory Monitor (Jul 17, 2015)
- K123690: CAPNOSTREAM20P with Hifi C02 Monitoring (Aug 5, 2014)
- K121927: Microstream Filterline Icu (Nov 29, 2012)
- K112368: CAPNOSTREAM20P with AI/Odi (Jul 19, 2012)
- K093388: Smart Capnoline Guardian (Mar 4, 2010)

Source page: https://510kreport.com/company/oridion-medical-1987