510(k) Report

FDA applicant

Reciprocal Labs Corporation

Madison, WI10 decisions2012–20200 recalls

FDA records 10 decisions for Reciprocal Labs Corporation (Madison, WI) from 2012 to 2020: 10 510(k) clearances. All are in product code CAF (Nebulizer (Direct Patient Interface)). Since 2016 its 510(k)s took a median of 160 days from receipt to decision, against 186 for FDA’s reviews in the same codes and years. Its devices cite 12 predicates, 11 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Reciprocal Labs”.

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 Reciprocal Labs Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2012: 12014: 12015: 32016: 32018: 12020: 1
2012high 3 (2015) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Reciprocal Labs Corporation by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Reciprocal Labs Corporation’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?

  • CAFNebulizer (Direct Patient Interface)10decisions

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 160 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 186 days; 4 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 12 predicates; 11 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 14 times; 11 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.

  • K142516Propeller SystemReciprocal Labs Corporation · 20154cite it
  • K140638Propeller System - Model 2Reciprocal Labs Corporation · 20144cite it
  • K142960Propeller System 2014-RReciprocal Labs · 20151cites it
  • K152882Propeller SystemReciprocal Labs · 20161cites it
  • K121609Asthmapolis SystemReciprocal Labs Corporation · 20121cites it
  • K180770Propeller Sensor for NeohalerReciprocal Labs Corporation · 20181cites it

What has FDA decided for it lately?

  • K192724Propeller Sensor for SymbicortReciprocal Labs Corporation · 2020
  • K180770Propeller Sensor for NeohalerReciprocal Labs Corporation · 2018
  • K161454Propeller Sensor Model 2015-EReciprocal Labs Corporation · 2016
  • K152882Propeller SystemReciprocal Labs · 2016
  • K152482Propeller Sensor Model 2014-RReciprocal Labs · 2016
  • K143671Propeller Model 2014-D SensorReciprocal Labs · 2015
  • K142516Propeller SystemReciprocal Labs Corporation · 2015
  • K142960Propeller System 2014-RReciprocal Labs · 2015

All 6 as Reciprocal Labs Corporation →All 4 as Reciprocal Labs →