510(k) Report

FDA applicant

Vitrolife Sweden AB

Washington, DC38 decisions2000–20251 recall

FDA records 38 decisions for Vitrolife Sweden AB (Washington, DC) from 2000 to 2025: 38 510(k) clearances. Most are in product codes MQL (Media, Reproductive) and MQE (Needle, Assisted Reproduction). Since 2016 its 510(k)s took a median of 156 days from receipt to decision, against 195 for FDA’s reviews in the same codes and years. Its devices cite 27 predicates, 12 of them its own earlier devices. 1 recall is linked to its devices.

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

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided Vitrolife Sweden AB’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2008: 62009: 22010: 12012: 12014: 12015: 12017: 22019: 22021: 12024: 22025: 1
2007high 6 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

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

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

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Which product codes does it file in?

  • MQLMedia, Reproductive28decisions
  • MQENeedle, Assisted Reproduction3decisions
  • MQKLabware, Assisted Reproduction3decisions
  • MSBSystem And Accessories, Isolated Heart, Transport And Preservation2decisions
  • MQFCatheter, Assisted Reproduction1decision
  • ITXTransducer, Ultrasonic, Diagnostic1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 156 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 195 days; 2 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 27 predicates; 12 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 25 times; 12 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.

  • K000881Perfadex Solution for Organ PreservationVitrolife Sweden AB · 20013cite it
  • K090832Rapid-IVitrolife Sweden AB · 20093cite it
  • K080446Rapidvit and Rapidwarm CleaveVitrolife Sweden AB · 20083cite it
  • K081115G-Mops G5 SeriesVitrolife Sweden AB · 20082cite it
  • K082727Follicle Aspiration Set, Reduced Single LumenVitrolife Sweden AB · 20092cite it
  • K021893G-Mops, Model 10030Vitrolife Sweden AB · 20022cite it

What has FDA decided for it lately?

  • K243373Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF…Vitrolife Sweden AB · 2025
  • K241662Ultrasound Transducer CoverVitrolife Sweden AB · 2024
  • K240605Ultra RapidWarm™ BlastVitrolife Sweden AB · 2024
  • K202862Gx-IVF, Gx-TL, Gx-MOPS PLUSVitrolife Sweden AB · 2021
  • K183486RapidVit™ Oocyte, RapidWarm™ OocyteVitrolife Sweden AB · 2019
  • K181461Rapid-i™ KitVitrolife Sweden AB · 2019
  • K172050Follicle Aspiration Set, Reduced Single LumenVitrolife Sweden AB · 2017
  • K161970Follicle Aspiration SetVitrolife Sweden AB · 2017

All 38 as Vitrolife Sweden AB →

What has been recalled?

1 recall linked to its devices; the latest:

  • K081997XVIVO Perfusion AB (Part of Vitrolife), THAM Solution, 3.3 mmol/ml, 50 mL, REF 99019…May 12, 2011

Other applicant names beginning “Vitrolife”

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

Vitrolife AB/Scandinavian Ivf Sciences AB 7Vitrolife AB 5Vitrolife A/S 4