Rondex Products, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Rondex Products, Inc.” (first 1984, latest 1998), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 73 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 |
|---|---|---|---|
| CBP | Valve, Non-Rebreathing | 6 | 6 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 3 | 3 |
| BSJ | Mask, Gas, Anesthetic | 2 | 2 |
Review panels
- Anesthesiology (11)
Most recent Rondex Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K981169 | RONDEX CPR ISO-SHIELD | CBP | 1998-05-19 | 50 |
| K942671 | CPR SHIELD | CBP | 1995-02-07 | 246 |
| K943761 | NON-BREATHING VALVE | CBP | 1994-11-10 | 100 |
| K921002 | RONDEX MASK MODELS 9122/9111/9102/911102, MODIFIED | BTM | 1992-10-06 | 224 |
| K914196 | RONDEX MASKS MODELS 9015/9011/901102 MODIFIED | BTM | 1991-11-08 | 64 |
| K914195 | RONDEX CPR NON REBREATHING VALVE #9030, MODIFIED | CBP | 1991-11-08 | 64 |
| K902299 | CPR VALVE (NON-REBREATHING) MODEL #9030 | CBP | 1990-10-26 | 157 |
| K902298 | ORAL-NASAL MASK RESUSCITATION AND ANESTHETIC GAS | BSJ | 1990-08-22 | 92 |
| K881931 | RESCUE MASK & CPR VALVE FOR MOUTH-TO-MASK TYPE CPR | CBP | 1988-07-21 | 73 |
| K881393 | RONDEX RESCUE MASK | BSJ | 1988-04-25 | 21 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Rondex Products, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Rondex Products, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Rondex Products, Inc.” (first 1984, latest 1998), across 3 product codes 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 Rondex Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Rondex Products, Inc. is 73 days.
Which FDA product codes appear under Rondex Products, Inc.?
The most frequent FDA product codes under this applicant name are CBP (Valve, Non-Rebreathing, 6); BTM (Ventilator, Emergency, Manual (Resuscitator), 3); BSJ (Mask, Gas, Anesthetic, 2).
Next steps
- See all 11 Rondex Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CBP, Rondex Products, Inc.'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.