Stryker Sustainability Solutions: FDA filings under this applicant name
FDA lists 34 510(k) clearances under the applicant name “Stryker Sustainability Solutions” (first 2011, latest 2026), across 11 product codes in 6 review panels. Median 510(k) review time under this name: 101 days. Since 2017 the median was 101 days, against 122 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Stryker, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 112 |
| 2013 | 2 | 110 |
| 2014 | 2 | 146 |
| 2015 | 1 | 114 |
| 2016 | 1 | 49 |
| 2017 | 3 | 57 |
| 2018 | 2 | 58 |
| 2019 | 2 | 270 |
| 2020 | 3 | 88 |
| 2021 | 1 | 194 |
| 2022 | 5 | 149 |
| 2023 | 3 | 56 |
| 2024 | 3 | 118 |
| 2025 | 1 | 142 |
| 2026 | 1 | 112 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Stryker Sustainability Solutions took a median 101 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 122 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NLQ | Single-Use Reprocessed Ultrasonic Surgical Instruments | 7 | 7 |
| NUJ | Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed | 7 | 7 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 4 | 4 |
| NLH | Catheter, Recording, Electrode, Reprocessed | 4 | 4 |
| NLF | Oximeter, Reprocessed | 3 | 3 |
| OWQ | Reprocessed Intravascular Ultrasound Catheter | 3 | 3 |
| NLM | Laparoscope, General & Plastic Surgery, Reprocessed | 2 | 2 |
| DQA | Oximeter | 1 | 1 |
| DYB | Introducer, Catheter | 1 | 1 |
| HIH | Hysteroscope (And Accessories) | 1 | 1 |
Plus 1 more product codes.
Review panels
- General and Plastic Surgery (18)
- Cardiovascular (8)
- Anesthesiology (4)
- Gastroenterology and Urology (2)
- Obstetrics and Gynecology (1)
- Orthopedic (1)
Most recent Stryker Sustainability Solutions 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260636 | Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating | GEI | 2026-06-18 | 112 |
| 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) | NLQ | 2025-08-14 | 142 |
| 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) | NLF | 2024-10-22 | 124 |
| K241606 | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm Length (HAR1136) | NLQ | 2024-07-03 | 29 |
| K233471 | Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136) | NLQ | 2024-02-20 | 118 |
| K231621 | Reprocessed ViewFlex Xtra ICE Catheter (D087031) | OWQ | 2023-07-25 | 53 |
| K230255 | Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019 | GEI | 2023-03-28 | 56 |
| K230251 | Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) | NUJ | 2023-03-28 | 57 |
| 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) | NLF | 2022-12-04 | 149 |
| K220481 | Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019) | GEI | 2022-05-25 | 96 |
24 earlier clearances. See the full list in Caduvo.
Recalls
72 product recalls in 37 recall events; 41 initiated in the last five years. Most recent: 2026-08-19.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Stryker Sustainability Solutions is the lead sponsor of 4 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT06149416: SpO2 Accuracy of Noninvasive Pulse Oximeter Sensor With Motion Conditions (Completed, started 2023-05-27)
- NCT05264116: SpO2 Accuracy of Noninvasive Disposable Pulse Oximeter Sensor With Motion Conditions (Completed, started 2022-02-02)
- NCT05245526: SpO2 Accuracy of Noninvasive Disposable Pulse Oximeter Sensor (Completed, started 2022-01-19)
- NCT05141500: SpO2 Accuracy of Noninvasive Pulse Oximeter Sensor (Completed, started 2021-11-02)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Stryker Corp. (352 510(k)s)
- Stryker Endoscopy (102 510(k)s)
- Stryker Spine (75 510(k)s)
- Stryker Instruments (75 510(k)s)
- Stryker Neurovascular (33 510(k)s)
- Stryker Trauma AG (25 510(k)s)
- Stryker Orthopaedics (24 510(k)s)
- Stryker Leibinger GmbH & Co KG (22 510(k)s)
- Stryker Medical (14 510(k)s)
- Stryker Leibinger (13 510(k)s)
- Stryker Trauma GmbH (7 510(k)s)
- Stryker Corporate (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Stryker Sustainability Solutions?
FDA lists 34 510(k) clearances under the applicant name “Stryker Sustainability Solutions” (first 2011, latest 2026), across 11 product codes in 6 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Stryker Sustainability Solutions?
The median time from FDA receipt to decision across 510(k)s cleared under the name Stryker Sustainability Solutions is 101 days. Since 2017: 101 days, versus 122 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Stryker Sustainability Solutions?
The most frequent FDA product codes under this applicant name are NLQ (Single-Use Reprocessed Ultrasonic Surgical Instruments, 7); NUJ (Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed, 7); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 4).
Next steps
- See all 34 Stryker Sustainability Solutions clearances with predicates and recalls
- Run predicate analysis for product code NLQ, Stryker Sustainability Solutions's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.