# Codonics, Inc.

- Location (FDA's records): Middleburg Heights, OH
- FDA decisions: 8 (1996–2025): 8 510(k) clearances
- Names in FDA's records: Codonics, Inc. (7); Codonics.Incorporated (1)
- Product codes: LMC (6), BSZ (2)
- Predicates its devices cite: 14 (7 its own); citations of its devices by later devices: 12 (7 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
- Seiko Instruments USA, Inc.: 2 (https://510kreport.com/company/seiko-instruments-usa)
- Agfa Corp.: 1 (https://510kreport.com/company/agfa)
- Alaris Medical Systems, Inc.: 1 (https://510kreport.com/company/alaris-medical-systems)
- Safer Sleep, LLC: 1 (https://510kreport.com/company/safer-sleep)
- Docusys: 1 (https://510kreport.com/company/docusys)
- Philips Medical Systems, Inc.: 1 (https://510kreport.com/company/philips-medical-systems)

## Firms that cite its devices most
- Virtual Imaging, Inc.: 2 (https://510kreport.com/company/virtual-imaging)
- Carestream Health, Inc.: 1 (https://510kreport.com/company/carestream-health)
- Eastman Kodak Company: 1 (https://510kreport.com/company/eastman-kodak)
- Sony Medical Systems: 1 (https://510kreport.com/company/sony-medical-systems)

## Its most-cited devices
- K021054: Codonics Horizon CI Medical Multimedia Dry Imager; Codonics Horizon GS Medical Multimedia Grey Scale Dry Imager (2002), cited by 4
- K030690: Codonics EP-1000 Medical Color Dry Imagers (2003), cited by 2
- K003481: Codonics NP-1660 Series Medical Printers, Model 1660 (2001), cited by 2
- K101439: Codonics Safe Labeling System (SLS), Model 500I/500P (2011), cited by 1
- K962364: Codonics Medical Printer (NP-1600M,NP1600MD) (1996), cited by 1
- K042232: NP-2600 Series Hardcopy Printers (2004), cited by 1

## Recent decisions
- K251352: Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration) (Jul 11, 2025)
- K101439: Codonics Safe Labeling System (SLS), Model 500I/500P (Feb 7, 2011)
- K060440: Codonics Horizon XL Digital Direct Long Film Imager; Codonics Horizon XL-X Long Film Imager (Mar 16, 2006)
- K042232: NP-2600 Series Hardcopy Printers (Oct 5, 2004)
- K030690: Codonics EP-1000 Medical Color Dry Imagers (Apr 30, 2003)
- K021054: Codonics Horizon CI Medical Multimedia Dry Imager; Codonics Horizon GS Medical Multimedia Grey Scale Dry Imager (May 9, 2002)
- K003481: Codonics NP-1660 Series Medical Printers, Model 1660 (Jan 19, 2001)
- K962364: Codonics Medical Printer (NP-1600M,NP1600MD) (Nov 8, 1996)

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