Equilibrated Bio Systems, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Equilibrated Bio Systems, Inc.” (first 1978, latest 1989), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 37 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 |
|---|---|---|---|
| JAY | Support, Breathing Tube | 2 | 2 |
| BTY | Calculator, Predicted Values, Pulmonary Function | 1 | 1 |
| BXX | Calibrator, Pressure, Gas | 1 | 1 |
| BZG | Spirometer, Diagnostic | 1 | 1 |
| DSP | System, Balloon, Intra-Aortic And Control | 1 | 1 |
| LCH | Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical | 1 | 1 |
Review panels
- Anesthesiology (5)
- Clinical Chemistry (1)
- Cardiovascular (1)
Most recent Equilibrated Bio Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K892705 | EBS2605 INFANT HUGGER | BTY | 1989-10-27 | 196 |
| K855102 | MONARK 869 ERGOMETER | DSP | 1986-05-09 | 137 |
| K843996 | TURBOAIRE CHALLANGER ENVIRONMENTAL AIR CONTROLLER | BZG | 1984-11-20 | 40 |
| K791294 | SPIROCAL | BXX | 1979-08-16 | 37 |
| K790410 | ADULT ZEE-FRAME | JAY | 1979-03-22 | 24 |
| K781509 | ZEE-FRAME | JAY | 1978-09-26 | 25 |
| K781386 | EBS 775 TONOMETER | LCH | 1978-09-14 | 34 |
Recalls
openFDA lists no recalls under a recalling firm named Equilibrated Bio Systems, 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 Equilibrated Bio Systems, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Equilibrated Bio Systems, Inc.” (first 1978, latest 1989), across 6 product codes in 3 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 Equilibrated Bio Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Equilibrated Bio Systems, Inc. is 37 days.
Which FDA product codes appear under Equilibrated Bio Systems, Inc.?
The most frequent FDA product codes under this applicant name are JAY (Support, Breathing Tube, 2); BTY (Calculator, Predicted Values, Pulmonary Function, 1); BXX (Calibrator, Pressure, Gas, 1).
Next steps
- See all 7 Equilibrated Bio Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JAY, Equilibrated Bio Systems, 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.