510(k) Report

FDA applicant

Spiration, Inc.

Redmond, WA5 decisions2015–20170 recalls

FDA records 5 decisions for Spiration, Inc. (Redmond, WA) from 2015 to 2017: 5 510(k) clearances. Most are in product codes EOQ (Bronchoscope (Flexible Or Rigid)) and GEI (Electrosurgical, Cutting & Coagulation &…). Since 2016 its 510(k)s took a median of 142 days from receipt to decision, against 136 for FDA’s reviews in the same codes and years. Its devices cite 6 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, ear, nose and throat panel, where it files most

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

FDA decisions per year

3in 2017

2015: 12016: 12017: 3
2015high 3 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Spiration, Inc. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Spiration, 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?

  • EOQBronchoscope (Flexible Or Rigid)3decisions
  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision
  • KTIBronchoscope Accessory1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 142 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 136 days; 1 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K162611PeriFLEXSpiration, Inc. · 20172cite it
  • K142909Flexible 19G EBUS NeedleSpiration, Inc. · 20151cites it
  • K152922ViziShot FLEXSpiration, Inc. · 20161cites it

What has FDA decided for it lately?

  • K171492B7 2C Occlusion BalloonSpiration, Inc. · 2017
  • K170990Active Needle Endoscopic Treatment (ANET) Electrosurgical ApplicatorSpiration, Inc. · 2017
  • K162611PeriFLEXSpiration, Inc. · 2017
  • K152922ViziShot FLEXSpiration, Inc. · 2016
  • K142909Flexible 19G EBUS NeedleSpiration, Inc. · 2015

All 5 as Spiration, Inc. →