Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Reciprocal Labs Corporation · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
159 daysmedian FDA review time
249 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K192724 | Propeller Sensor for Symbicort | Reciprocal Labs Corporation | 2020-03-26 | 181 | 0 |
| K180770 | Propeller Sensor for Neohaler | Reciprocal Labs Corporation | 2018-08-01 | 131 | 0 |
| K161454 | Propeller Sensor Model 2015-E | Reciprocal Labs Corporation | 2016-11-01 | 159 | 0 |
| K142516 | Propeller System | Reciprocal Labs Corporation | 2015-05-15 | 249 | 0 |
| K140638 | PROPELLER SYSTEM - MODEL 2 | Reciprocal Labs Corporation | 2014-05-02 | 51 | 0 |
| K121609 | ASTHMAPOLIS SYSTEM | Reciprocal Labs Corporation | 2012-07-02 | 31 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda