Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Organon, Inc. — Predicate Candidate Screening
41 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
30 daysmedian FDA review time
76 days90th percentile
41clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K950861 | RECONSTITUTION ACCESSOREIS | Organon, Inc. | 1995-05-26 | 88 | 0 |
| K853388 | MONOSTICON UNI-DOT | Organon, Inc. | 1985-08-22 | 9 | 0 |
| K842314 | DUOCLON COLOR-CEPT | Organon, Inc. | 1984-08-24 | 73 | 0 |
| K841525 | OREIA II B-HCG PREGNANCY TEST KIT | Organon, Inc. | 1984-06-05 | 54 | 0 |
| K841602 | ACCURATE BETA 30 PREGNANCY TEST KIT | Organon, Inc. | 1984-05-22 | 34 | 0 |
| K840650 | B-NEOCEPT 30 | Organon, Inc. | 1984-04-04 | 49 | 0 |
| K832801 | OREIA II B-HCG, ENZYME INNUNOASSAY | Organon, Inc. | 1983-12-08 | 112 | 0 |
| K831339 | NEO-PREGNOSTICON DUOCLON TUBE TEST | Organon, Inc. | 1983-06-08 | 44 | 0 |
| K831109 | DUOCLON SLIDE TEST | Organon, Inc. | 1983-06-02 | 58 | 0 |
| K823682 | BETA FFIRM TEST | Organon, Inc. | 1983-01-07 | 31 | 0 |
| K812967 | ACCURATE BETA | Organon, Inc. | 1981-11-06 | 15 | 0 |
| K812334 | B-NEOCEPT | Organon, Inc. | 1981-09-01 | 14 | 0 |
| K812261 | ACCURATE I | Organon, Inc. | 1981-08-31 | 19 | 0 |
| K811940 | OREIA II, B-HCG | Organon, Inc. | 1981-08-03 | 28 | 0 |
| K811941 | NEOCEPT | Organon, Inc. | 1981-07-27 | 21 | 0 |
| K802974 | RAPI-DOT | Organon, Inc. | 1980-12-19 | 28 | 0 |
| K802634 | STERIGAGE EO ETHYL. OXIDE STERIL. INDIC. | Organon, Inc. | 1980-12-11 | 50 | 0 |
| K802693 | OREIA-Q-TY, ENZYME IMMUNOASSAY | Organon, Inc. | 1980-12-10 | 41 | 0 |
| K802464 | OREAI-Q-TU TEST | Organon, Inc. | 1980-10-31 | 22 | 0 |
| K802358 | OREIA-Q-DIG | Organon, Inc. | 1980-10-10 | 14 | 0 |
| K801159 | STREPTO-SEC TM | Organon, Inc. | 1980-06-20 | 40 | 0 |
| K791172 | OREIA-TU THYROID UPTAKER RATIO ASSAY | Organon, Inc. | 1979-10-30 | 127 | 0 |
| K791723 | QUANTAFFIRM CPK ISO ENZYME SERUM (HUMAN) | Organon, Inc. | 1979-10-01 | 32 | 0 |
| K790734 | PREGNOSTICON PREGNANCY TEST KIT | Organon, Inc. | 1979-06-15 | 60 | 0 |
| K790521 | OREIA - DIGOXIN | Organon, Inc. | 1979-04-10 | 25 | 0 |
| K790122 | RUBANON | Organon, Inc. | 1979-02-15 | 23 | 0 |
| K781554 | RAD-291 | Organon, Inc. | 1978-10-11 | 30 | 0 |
| K780308 | OREIA-T4 | Organon, Inc. | 1978-04-12 | 48 | 0 |
| K780240 | PREDICTOR | Organon, Inc. | 1978-02-27 | 14 | 0 |
| K780063 | RUBENOSTICON | Organon, Inc. | 1978-01-20 | 8 | 0 |
| K772086 | QUANTROLS HCG | Organon, Inc. | 1977-11-23 | 20 | 0 |
| K771941 | QUANTROLS IM | Organon, Inc. | 1977-11-02 | 16 | 0 |
| K771940 | QUANTROLS RF | Organon, Inc. | 1977-11-02 | 16 | 0 |
| K770603 | HYPRONOSTICON TM | Organon, Inc. | 1977-09-02 | 156 | 0 |
| K771410 | RHEUMANOSTICON R | Organon, Inc. | 1977-09-02 | 32 | 0 |
| K771397 | MONOSTICON TEST | Organon, Inc. | 1977-08-22 | 24 | 0 |
| K771305 | LIQUAEMIN SODIUM, HEPARIN SODIUM ETC. | Organon, Inc. | 1977-08-04 | 21 | 0 |
| K771304 | LIQUAEMIB SODIUM PRESERVATIVE, ETC. | Organon, Inc. | 1977-08-04 | 21 | 0 |
| K771038 | THERMOMETER, SINGLE USE, STRIP, TEMPADOT | Organon, Inc. | 1977-06-27 | 17 | 0 |
| K770605 | TUBES, HYDROLYSIS, CALIBRATED | Organon, Inc. | 1977-06-15 | 76 | 0 |
| K770597 | DASP TM ANTI-RABBIT | Organon, Inc. | 1977-04-28 | 30 | 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