510(k) Report

FDA applicant

Iob Medical, Inc.

Gaithersburg, MD7 decisions2014–20230 recalls

FDA records 7 decisions for Iob Medical, Inc. (Gaithersburg, MD) from 2014 to 2023: 7 510(k) clearances. Most are in product codes DWJ (System, Thermal Regulating) and FXX (Mask, Surgical). Since 2016 its 510(k)s took a median of 135 days from receipt to decision, against 98 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 6 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 Iob Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2023

2014: 12017: 12019: 12021: 12022: 12023: 2
2014high 2 (2023) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Iob Medical, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Iob Medical, Inc.’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?

  • DWJSystem, Thermal Regulating5decisions
  • FXXMask, Surgical1decision
  • HIBSpeculum, Vaginal, Nonmetal1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 135 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 98 days; 1 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 8 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 6 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.

  • K162679IOB Temperature Management SystemIob Medical, Inc. · 20173cite it
  • K231596IOB Temperature Management SystemIob Medical, Inc. · 20232cite it
  • K190221IOB Warming BlanketsIob Medical, Inc. · 20192cite it
  • K221669IOB Warming BlanketsIob Medical, Inc. · 20221cites it

What has FDA decided for it lately?

  • K232638FilteredFlo Warming BlanketsIob Medical, Inc. · 2023
  • K231596IOB Temperature Management SystemIob Medical, Inc. · 2023
  • K221669IOB Warming BlanketsIob Medical, Inc. · 2022
  • K201896ivi N3003 Surgical face Mask, ivi N6006 Surgical maskIob Medical, Inc. · 2021
  • K190221IOB Warming BlanketsIob Medical, Inc. · 2019
  • K162679IOB Temperature Management SystemIob Medical, Inc. · 2017
  • K132668Iob Disposable SpeculumIob Medical, Inc. · 2014

All 7 as Iob Medical, Inc. →