Bib, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Bib, Inc.” (first 1980, latest 1983), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 50 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 |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | 2 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 | 1 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
| KRE | Analyzer, Pacemaker Generator Function, Indirect | 1 | 1 |
Review panels
- Cardiovascular (4)
- General Hospital (1)
Most recent Bib, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K830916 | VITA/TRAC 4 FUNCTION VITAL SIGN MONITOR | DRT | 1983-07-07 | 107 |
| K801389 | BARO/TRAC II & VITA/TRAC, VITAL SIGN MON | DXN | 1980-07-28 | 45 |
| K801366 | DISPOSABLE TEMPERATURE PROBE COVER | FLL | 1980-07-28 | 48 |
| K800596 | VITA/TRAC 4-FUNCTION VITAL SIGN MONITOR | DXN | 1980-07-21 | 126 |
| K800782 | PACE-PULSE/COMPUTRAC | KRE | 1980-05-28 | 50 |
Recalls
openFDA lists no recalls under a recalling firm named Bib, 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 Bib, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Bib, Inc.” (first 1980, latest 1983), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Bib, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bib, Inc. is 50 days.
Which FDA product codes appear under Bib, Inc.?
The most frequent FDA product codes under this applicant name are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 2); DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), 1); FLL (Continuous Measurement Thermometer, 1).
Next steps
- See all 5 Bib, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXN, Bib, 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.