Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Erich Jaeger, Inc. — Predicate Candidate Screening
28 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
64 daysmedian FDA review time
272 days90th percentile
28clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K000396 | APNOESCREEN PRO, ALPHA SCREEN PRO | Erich Jaeger, Inc. | 2000-12-27 | 324 | 0 |
| K972419 | TOENNIES NEUROSCREEN SYSTEM | Erich Jaeger, Inc. | 1998-04-30 | 307 | 0 |
| K960078 | ASTHMA MONITOR | Erich Jaeger, Inc. | 1996-09-20 | 259 | 0 |
| K932744 | FLOWSCREEN | Erich Jaeger, Inc. | 1994-03-07 | 272 | 0 |
| K933839 | MASTER SCREEN PNUEMO | Erich Jaeger, Inc. | 1994-03-07 | 214 | 0 |
| K853443 | ALVEO-DIFFUSION TEST | Erich Jaeger, Inc. | 1986-02-21 | 189 | 0 |
| K853390 | INFANT BODY TEST | Erich Jaeger, Inc. | 1986-02-05 | 176 | 0 |
| K853434 | ERGO-PNEUMOTEST | Erich Jaeger, Inc. | 1986-02-05 | 174 | 0 |
| K853409 | SCREENMATE | Erich Jaeger, Inc. | 1986-02-05 | 177 | 0 |
| K853360 | N20 TEST | Erich Jaeger, Inc. | 1985-09-03 | 22 | 0 |
| K852337 | PNEUMOSCOPE | Erich Jaeger, Inc. | 1985-07-01 | 31 | 0 |
| K843846 | UNIVERSAL-BODYTEST | Erich Jaeger, Inc. | 1985-02-14 | 136 | 0 |
| K843851 | BODYSCREEN II | Erich Jaeger, Inc. | 1985-02-14 | 136 | 0 |
| K843841 | ERGO-OXYSCREEN | Erich Jaeger, Inc. | 1984-12-27 | 87 | 0 |
| K843860 | OXYSCREEN | Erich Jaeger, Inc. | 1984-12-27 | 87 | 0 |
| K843843 | HE TEST | Erich Jaeger, Inc. | 1984-12-04 | 64 | 0 |
| K843855 | ERGOTEST 40 & 45 | Erich Jaeger, Inc. | 1984-11-27 | 57 | 0 |
| K843859 | LAUF-ERGOTEST JUNIOR | Erich Jaeger, Inc. | 1984-11-27 | 57 | 0 |
| K843850 | UNIVERSAL-ERGOTEST | Erich Jaeger, Inc. | 1984-11-27 | 57 | 0 |
| K843853 | LAUF-ERGOTEST | Erich Jaeger, Inc. | 1984-11-27 | 57 | 0 |
| K843857 | TRANSFERSCREEN II | Erich Jaeger, Inc. | 1984-11-08 | 38 | 0 |
| K843852 | APTA-BRONCHOSCREEN | Erich Jaeger, Inc. | 1984-11-01 | 31 | 0 |
| K843848 | AW TEST | Erich Jaeger, Inc. | 1984-11-01 | 31 | 0 |
| K843849 | PNEUMOSCREEN | Erich Jaeger, Inc. | 1984-10-16 | 15 | 0 |
| K843840 | N2 TEST | Erich Jaeger, Inc. | 1984-10-12 | 11 | 0 |
| K843844 | CO2 TEST | Erich Jaeger, Inc. | 1984-10-12 | 11 | 0 |
| K843847 | O2 TEST | Erich Jaeger, Inc. | 1984-10-12 | 11 | 0 |
| K843845 | CO TEST | Erich Jaeger, Inc. | 1984-10-12 | 11 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda