510(k) Report

FDA applicant

Stryker Instruments

Kalamazoo, MI77 decisions1994–2026244 recalls

FDA records 77 decisions for Stryker Instruments (Kalamazoo, MI) from 1994 to 2026: 77 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and HAW (Neurological Stereotaxic Instrument). Since 2016 its 510(k)s took a median of 93 days from receipt to decision, against 122 for FDA’s reviews in the same codes and years. Its devices cite 130 predicates, 23 of them its own earlier devices. 244 recalls are linked to its devices, 4 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Stryker Instruments’s devices, and how often a recall has named them.

FDA decisions per year

8in 2025

2007: 12017: 12021: 12022: 22023: 12024: 42025: 82026 (partial year): 6
2007high 8 (2025) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2024

2008: 662009: 972010: 472011: 72012: 6, 4 Class I2013: 42014: 12015: 52024: 1
2007high 97 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Stryker Instruments by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Stryker Instruments’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories8decisions
  • HAWNeurological Stereotaxic Instrument6decisions
  • FYAGown, Surgical5decisions
  • JEYPlate, Bone5decisions
  • FRNPump, Infusion4decisions
  • GXPMethyl Methacrylate For Cranioplasty3decisions

Also: GXI (3), NDN (2), LFL (2), FQH (2), HBE (2), NKB (2).

How long do its 510(k) reviews take?

Since 2016, its 18 510(k)s took a median of 93 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 122 days; 13 of its 18 were faster than that.

Whose devices does it build on?

Its devices cite 130 predicates; 23 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 113 times; 23 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K022185Universal CMF SystemStryker Instruments · 200212cite it
  • K022365Stryker Navigation System - Hip ModuleStryker Instruments · 20037cite it
  • K991696Stryker Hermes-Ready Total Performance SystemStryker Instruments · 19996cite it
  • K043334Bone Source Hac Rapid Setting CementStryker Instruments · 20055cite it
  • K014263Newgen/Universal Mandibular SystemStryker Instruments · 20025cite it
  • K032473Dekompressor Percutaneous Discectomy ProbeStryker Instruments · 20035cite it

What has FDA decided for it lately?

  • K262386SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000);SafeAir Generator 3-Pedal Footswitch…Stryker Instruments · 2026
  • K262244Sonopet iQ Series III Console (5700-050-000); Sonopet iQ+ Straight Handpiece (5500-260-000); Sonopet iQ+…Stryker Instruments · 2026
  • K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch…Stryker Instruments · 2026
  • K261544Hydro Irrigation SystemStryker Instruments · 2026
  • K253679Hydro Irrigation SystemStryker Instruments · 2026
  • K252282SurgiCount+ SystemStryker Instruments · 2026
  • K251971RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS…Stryker Instruments · 2025
  • K250483PhotonBlade 3; PhotonBlade 3 Smoke EvacuationStryker Instruments · 2025

All 77 as Stryker Instruments →

What has been recalled?

244 recalls linked to its devices; the latest:

  • K032406This product is a single use sterile device that is used to direct the lesion to the…Jun 3, 2024Class II
  • K022365Navigation System II-Cart, 7700-100-000 with Articulated Arm Camera, 7700-103-001 and…May 4, 2015Class II
  • K9707141/4 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with…Mar 26, 2015Class II
  • K9707141/8 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with…Mar 26, 2015Class II
  • K970714Ambulating Bulb Ambulating Bulb: The Ambulating Bulb comprises four main components: the…Mar 26, 2015Class II
  • K9707143/16 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar…Mar 26, 2015Class II

Other applicant names beginning “Stryker”

FDA records each applicant name separately; these may or may not be the same firm.

Stryker Corp. 354Stryker Endoscopy 103Stryker Spine 76Stryker Leibinger GmbH & Co KG 36Stryker Neurovascular 36Stryker Sustainability Solutions 34Stryker Trauma AG 32Stryker Orthopaedics 24Stryker Medical 14Stryker Instruments, Instruments Div. 6Stryker Corporate 6Stryker Corporation (Tornier, Inc.) 5