510(k) Report

FDA applicant

Sibel Health, Inc.

Chicago, IL5 decisions2023–20260 recalls

FDA records 5 decisions for Sibel Health, Inc. (Chicago, IL) from 2023 to 2026: 5 510(k) clearances. Most are in product codes DRG (Transmitters And Receivers, Physiological…) and DQA (Oximeter). Since 2016 its 510(k)s took a median of 121 days from receipt to decision, against 249 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 3 of them its own earlier devices. No 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, cardiovascular panel, where it files most

How often FDA has decided Sibel Health, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2023: 12024: 22025: 12026 (partial year): 1
2023high 2 (2024) · low 1 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Sibel Health, Inc. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Sibel Health, Inc.’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?

  • DRGTransmitters And Receivers, Physiological Signal, Radiofrequency2decisions
  • DQAOximeter1decision
  • MSXSystem, Network And Communication, Physiological Monitors1decision
  • HGMSystem, Monitoring, Perinatal1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 121 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 249 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 7 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 3 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.

  • K223711ANNE OneSibel Health, Inc. · 20234cite it
  • K242842ANNE View, Central HubSibel Health, Inc. · 20251cites it

What has FDA decided for it lately?

  • K253021ANNE MaternalSibel Health, Inc. · 2026
  • K242842ANNE View, Central HubSibel Health, Inc. · 2025
  • K240251ANNE ChestSibel Health, Inc. · 2024
  • K240305ANNE LimbSibel Health, Inc. · 2024
  • K223711ANNE OneSibel Health, Inc. · 2023

All 5 as Sibel Health, Inc. →

Other applicant names beginning “Sibel”

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

Sibel, Inc. 3