Erich Jaeger, Inc.: FDA filings under this applicant name
FDA lists 33 510(k) clearances under the applicant name “Erich Jaeger, Inc.” (first 1984, latest 2003), across 16 product codes in 3 review panels. Median 510(k) review time under this name: 64 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 |
|---|---|---|---|
| BZC | Calculator, Pulmonary Function Data | 7 | 7 |
| BZG | Spirometer, Diagnostic | 4 | 4 |
| CCM | Plethysmograph, Pressure | 4 | 4 |
| BTY | Calculator, Predicted Values, Pulmonary Function | 3 | 3 |
| IOL | Treadmill, Powered | 2 | 2 |
| MNR | Ventilatory Effort Recorder | 2 | 2 |
| BSE | Analyzer, Gas, Helium, Gaseous-Phase | 1 | 1 |
| BZL | Computer, Oxygen-Uptake | 1 | 1 |
| CBR | Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | 1 | 1 |
| CCJ | Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase | 1 | 1 |
Plus 6 more product codes.
Review panels
- Anesthesiology (26)
- Physical Medicine (4)
- Neurology (1)
Most recent Erich Jaeger, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K023120 | OXYCON MOBILE | BZC | 2003-11-12 | 419 |
| K023796 | MS PAED-BABY BODY | CCM | 2003-03-03 | 110 |
| K021138 | SLEEPSCREEN/APNOESCREEN CARDIO | MNR | 2003-02-12 | 309 |
| K000396 | APNOESCREEN PRO, ALPHA SCREEN PRO | MNR | 2000-12-27 | 324 |
| K001502 | AEROSOL PROVOCATION SYSTEM APS PRO, MODEL APS PRO | BZC | 2000-07-12 | 58 |
| K000648 | SPIRO PRO | BTY | 2000-03-29 | 30 |
| K972419 | TOENNIES NEUROSCREEN SYSTEM | IKN | 1998-04-30 | 307 |
| K960078 | ASTHMA MONITOR | BZG | 1996-09-20 | 259 |
| K933839 | MASTER SCREEN PNUEMO | BTY | 1994-03-07 | 214 |
| K932744 | FLOWSCREEN | BTY | 1994-03-07 | 272 |
23 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Erich Jaeger, 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.
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.
- Erich Jaeger GmbH & Co. KG (4 510(k)s)
- Erich Jaeger B.V. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Erich Jaeger, Inc.?
FDA lists 33 510(k) clearances under the applicant name “Erich Jaeger, Inc.” (first 1984, latest 2003), across 16 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 Erich Jaeger, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Erich Jaeger, Inc. is 64 days.
Which FDA product codes appear under Erich Jaeger, Inc.?
The most frequent FDA product codes under this applicant name are BZC (Calculator, Pulmonary Function Data, 7); BZG (Spirometer, Diagnostic, 4); CCM (Plethysmograph, Pressure, 4).
Next steps
- See all 33 Erich Jaeger, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BZC, Erich Jaeger, 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.