510(k) Report

FDA applicant

Shape Medical Systems, Inc.

St. Paul, MN2 decisions2009–20162 recalls

FDA records 2 decisions for Shape Medical Systems, Inc. (St. Paul, MN) from 2009 to 2016: 2 510(k) clearances. All are in product code BTY (Calculator, Predicted Values, Pulmonary Function). Its devices cite 3 predicates, 1 of them its own earlier devices. 2 recalls are linked to its devices.

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

FIG. A — Illustration, anesthesiology panel, where it files most

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

FDA decisions per year

1in 2016

2009: 12016: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

2in 2014

2014: 2
2009high 2 (2014) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Shape Medical Systems, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Shape Medical Systems, 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?

  • BTYCalculator, Predicted Values, Pulmonary Function2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K090722Shape-HF Cardiopulmonary Exercise Testing SystemShape Medical Systems, Inc. · 20092cite it

What has FDA decided for it lately?

  • K150888Shape-HF Cardiopulmonary Testing SystemShape Medical Systems, Inc. · 2016
  • K090722Shape-HF Cardiopulmonary Exercise Testing SystemShape Medical Systems, Inc. · 20092 recalls

All 2 as Shape Medical Systems, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K090722Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number…Dec 23, 2014Class II
  • K090722Shape HF Cardiopulmonary System. Made up of Shape HF System Analyzer (PN 0001-9001) and…May 28, 2014Class II

Other applicant names beginning “Shape”

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

Shape Memory Medical 2Shape Products Co. 1