Snap Laboratories, LLC: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Snap Laboratories, LLC” (first 1995, latest 2008), across 1 product code in 1 review panel. Median 510(k) review time under this name: 196 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MNR | Ventilatory Effort Recorder | 6 | 6 |
Review panels
- Anesthesiology (6)
Most recent Snap Laboratories, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K080321 | SNAP MODEL 7 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM | MNR | 2008-05-23 | 107 |
| K002095 | SNAP MODEL 6 | MNR | 2001-03-02 | 234 |
| K992322 | SNAP MODEL 5 | MNR | 2000-02-02 | 205 |
| K984169 | DIGI-SNAP | MNR | 1999-05-26 | 187 |
| K971184 | OXI-SNAP | MNR | 1997-10-01 | 183 |
| K944524 | SNAP TESTING DEVICE | MNR | 1995-10-26 | 405 |
Recalls
openFDA lists no recalls under a recalling firm named Snap Laboratories, LLC.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Snap Diagnostics, LLC (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Snap Laboratories, LLC?
FDA lists 6 510(k) clearances under the applicant name “Snap Laboratories, LLC” (first 1995, latest 2008), 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 Snap Laboratories, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Snap Laboratories, LLC is 196 days.
Which FDA product codes appear under Snap Laboratories, LLC?
The most frequent FDA product codes under this applicant name are MNR (Ventilatory Effort Recorder, 6).
Next steps
- See all 6 Snap Laboratories, LLC clearances with predicates and recalls
- Run predicate analysis for product code MNR, Snap Laboratories, LLC'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.