# Stryker Sustainability Solutions

- Location (FDA's records): Tempe, AZ
- FDA decisions: 34 (2011–2026): 34 510(k) clearances
- Names in FDA's records: Stryker Sustainability Solutions (32); Stryker Sustainability Solutions, Inc. (2)
- Product codes: NUJ (7), NLQ (7), NLH (4), GEI (4), NLF (3), OWQ (3), NLM (2), HIH (1), KTT (1), DYB (1), DQA (1)
- 510(k) review time since 2016: median 74 days, against 99 for FDA's reviews in the same codes and years (9 of 14 faster)
- Predicates its devices cite: 61 (7 its own); citations of its devices by later devices: 7 (7 its own)
- Recalls linked to its devices: 15 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ethicon Endo-Surgery, Inc.: 10 (https://510kreport.com/company/ethicon-endo-surgery)
- Irvine Biomedical, Inc.: 7 (https://510kreport.com/company/irvine-biomedical)
- Ascent Healthcare Solutions: 6 (https://510kreport.com/company/ascent-healthcare-solutions)
- Biosense Webster, Inc.: 4 (https://510kreport.com/company/biosense-webster)
- Covidien: 4 (https://510kreport.com/company/covidien)
- Hologic, Inc.: 3 (https://510kreport.com/company/hologic)
- Masimo Corporation: 3 (https://510kreport.com/company/masimo)
- St Jude Medical: 3 (https://510kreport.com/company/st-jude-medical)

## Its most-cited devices
- K222019: Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001), Reprocessed RD SET Inf Pulse Oximeter Sensor (4002), Reprocessed RD SET Adt Pulse Oximeter Sensor (4003) (2022), cited by 1
- K202554: Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis (2021), cited by 1
- K233471: Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136) (2024), cited by 1
- K211140: Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Transducer), Reprocessed Masimo Pulse Oximeter (1861 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (1862 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2317 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2319 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (2320 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2328 Infant O2 (2022), cited by 1
- K182238: Reprocessed ViewFlex Xtra ICE Catheter (2019), cited by 1
- K220481: Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019) (2022), cited by 1

## Recent decisions
- K260636: Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating (Jun 18, 2026)
- K250898: Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 23cm); Reprocessed HARMONIC 700 Shears (HAR736/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 36cm); Reprocessed HARMONIC 700 Shears (HAR745/Reprocessed HARMONIC 700, 5mm Diameter SHears with Advanced Hemostasis x 45cm) (Aug 14, 2025)
- K241758: Reprocessed RD SET Adt Pulse Oximeter Sensor  (4000); Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001); Reprocessed RD SET Inf Pulse Oximeter Sensor (4002); Reprocessed RD SET Adt Pulse Oximeter Sensor (4003) (Oct 22, 2024)
- K241606: Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm Length (HAR1136) (Jul 3, 2024)
- K233471: Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136) (Feb 20, 2024)
- K231621: Reprocessed ViewFlex Xtra ICE Catheter (D087031) (Jul 25, 2023)
- K230251: Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) (Mar 28, 2023)
- K230255: Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019 (Mar 28, 2023)

Source page: https://510kreport.com/company/stryker-sustainability-solutions