Yellow Springs Instrument Co., Inc.: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “Yellow Springs Instrument Co., Inc.” (first 1978, latest 1996), across 9 product codes in 5 review panels. Median 510(k) review time under this name: 58 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 |
|---|---|---|---|
| FLL | Continuous Measurement Thermometer | 10 | 10 |
| CGA | Glucose Oxidase, Glucose | 3 | 3 |
| BZT | Stethoscope, Esophageal, With Electrical Conductors | 2 | 2 |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 2 | 2 |
| KHP | Acid, Lactic, Enzymatic Method | 2 | 2 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 | 1 |
| EZL | Catheter, Retention Type, Balloon | 1 | 1 |
| FMT | Warmer, Infant Radiant | 1 | 1 |
| HHP | Table, Obstetrical, Manual (And Accessories) | 1 | 1 |
Review panels
- General Hospital (11)
- Clinical Chemistry (6)
- Anesthesiology (4)
- Gastroenterology and Urology (1)
- Obstetrics and Gynecology (1)
Most recent Yellow Springs Instrument Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K962070 | YSI 400 SERIES ATUOCLAVABLE REUSABLE TEMPERATURE PROBE | FLL | 1996-07-19 | 52 |
| K922821 | YSI MODELS 4700 FOLEY CATHETER TEMPERATURE PROBES | EZL | 1992-11-23 | 165 |
| K922007 | YSI MODEL 441A AIRWAY TEMPERATURE PROBE | BZT | 1992-11-04 | 188 |
| K910633 | YSI MODEL 1500 BLOOD GLUCOSE ANALYZER | CGA | 1991-04-12 | 58 |
| K910718 | YSI PRECISION 4000 THERMOMETER | FLL | 1991-04-09 | 48 |
| K901131 | YSI MODEL 1500 SPORT L-LACTATE ANALYZER | KHP | 1990-08-27 | 168 |
| K893409 | YSI MODELS 4400 & 4700 ESOPHAGEAL STETHOSCOPE TEMP | BZT | 1989-07-20 | 71 |
| K891480 | YSI MODEL 2300 STAT GLUCOSE AND L-LACTATE ANALYZER | CGA | 1989-05-22 | 66 |
| K883793 | DISPOSABLE TEMPERATURE PROBES (SEVERAL MODELS) | FLL | 1988-11-21 | 75 |
| K865012 | YSI MODEL 801 | FMT | 1987-03-04 | 71 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Yellow Springs Instrument Co., 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 Yellow Springs Instrument Co., Inc.?
FDA lists 23 510(k) clearances under the applicant name “Yellow Springs Instrument Co., Inc.” (first 1978, latest 1996), across 9 product codes in 5 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 Yellow Springs Instrument Co., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Yellow Springs Instrument Co., Inc. is 58 days.
Which FDA product codes appear under Yellow Springs Instrument Co., Inc.?
The most frequent FDA product codes under this applicant name are FLL (Continuous Measurement Thermometer, 10); CGA (Glucose Oxidase, Glucose, 3); BZT (Stethoscope, Esophageal, With Electrical Conductors, 2).
Next steps
- See all 23 Yellow Springs Instrument Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code FLL, Yellow Springs Instrument Co., 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.