Reciprocal Labs Corporation: FDA filings under this applicant name
FDA lists 10 510(k) clearances under 2 spellings of the applicant name “Reciprocal Labs Corporation” (first 2012, latest 2020), across 1 product code in 1 review panel. Median 510(k) review time under this name: 160 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 31 |
| 2013 | 0 | — |
| 2014 | 1 | 51 |
| 2015 | 3 | 178 |
| 2016 | 3 | 160 |
| 2017 | 0 | — |
| 2018 | 1 | 131 |
| 2019 | 0 | — |
| 2020 | 1 | 181 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Reciprocal Labs Corporation took a median 156 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 236 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | 10 | 10 |
Review panels
- Anesthesiology (10)
Most recent Reciprocal Labs Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K192724 | Propeller Sensor for Symbicort | CAF | 2020-03-26 | 181 |
| K180770 | Propeller Sensor for Neohaler | CAF | 2018-08-01 | 131 |
| K161454 | Propeller Sensor Model 2015-E | CAF | 2016-11-01 | 159 |
| K152882 | Propeller System | CAF | 2016-03-08 | 160 |
| K152482 | Propeller Sensor Model 2014-R | CAF | 2016-03-04 | 186 |
| K143671 | Propeller Model 2014-D Sensor | CAF | 2015-06-19 | 178 |
| K142516 | Propeller System | CAF | 2015-05-15 | 249 |
| K142960 | Propeller System 2014-R | CAF | 2015-03-05 | 142 |
| K140638 | PROPELLER SYSTEM - MODEL 2 | CAF | 2014-05-02 | 51 |
| K121609 | ASTHMAPOLIS SYSTEM | CAF | 2012-07-02 | 31 |
Recalls
openFDA lists no recalls under a recalling firm named Reciprocal Labs Corporation.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Reciprocal Labs Corporation is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01509183: Effectiveness of the Propeller Health (Formerly Asthmapolis) Monitoring System (Completed, started 2012-04)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Reciprocal Labs Corporation (a text match, not an official crosswalk):
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Reciprocal Labs Corporation (6)
- Reciprocal Labs (4)
Frequently asked questions
How many FDA 510(k) clearances are listed under Reciprocal Labs Corporation?
FDA lists 10 510(k) clearances under 2 spellings of the applicant name “Reciprocal Labs Corporation” (first 2012, latest 2020), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Reciprocal Labs Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Reciprocal Labs Corporation is 160 days.
Which FDA product codes appear under Reciprocal Labs Corporation?
The most frequent FDA product codes under this applicant name are CAF (Nebulizer (Direct Patient Interface), 10).
Next steps
- See all 10 Reciprocal Labs Corporation clearances with predicates and recalls
- Run predicate analysis for product code CAF, Reciprocal Labs Corporation's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.