510(k) Report

FDA applicant

Quantum Devices, Inc.

Grayslake, IL2 decisions2003–20120 recalls

FDA records 2 decisions for Quantum Devices, Inc. (Grayslake, IL) from 2003 to 2012: 2 510(k) clearances. All are in product code ILY (Lamp, Infrared, Therapeutic Heating). Its devices cite 4 predicates, 1 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, physical medicine panel, where it files most

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

FDA decisions per year

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • ILYLamp, Infrared, Therapeutic Heating2decisions

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 15 times; 1 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.

  • K032229Quantum Warp 10 Light Delivery SystemQuantum Devices, Inc. · 200315cite it

What has FDA decided for it lately?

  • K113231WARP10,WARP75Quantum Devices, Inc. · 2012
  • K032229Quantum Warp 10 Light Delivery SystemQuantum Devices, Inc. · 2003

All 2 as Quantum Devices, Inc. →

Other applicant names beginning “Quantum”

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

Quantum Orthopedics, Inc. 6Quantum Medical Imaging, LLC 5Quantum Medical Systems, Inc. 5Quantum Bioengineering, Ltd. 4Quantum Co., Ltd. 3Quantum Medical Concepts, LLC 2Quantum Instruments Corp. 2Quantum Surgical Sas 2Quantum Skincare, Inc. 1Quantum Intl. 1Quantum Medical Imaging Divison of Carestream 1Quantum Life Systems, Inc. 1