Atlas FDA

FMH

23 FDA 510(k) clearances · Product code

36 daysmedian time to decision
81 days90th percentile
23clearances measured

FDA profile

Official device name
Container, Specimen, Sterile
Device class
Class I (low risk)
Regulation
21 CFR 864.3250
Medical specialty
Pathology
Adverse events (MAUDE)
2021: 22 · 2022: 20 · 2023: 43 · 2024: 39 · 2025: 75 · 2026: 85
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
TRI-TECH URINE SPECIMEN KIT (K900983)Tri-Tech, Inc.1990-09-17
VARIOUS-SPECIMEN COLLECTORS (K823763)Cordis Corp.1983-01-19
CALCULI FILTER CUP (K820180)Omnimedical1982-02-05
LANCER SPECIMEN CONTAINER (K812933)Sherwood Medical Co.1981-11-06
SPECIMEN SET (K802340)American Pharmaseal Div. Ahsc1980-10-10
URINE SPECIMEN CONTAINER #'S 1013-1016 (K802002)Pollak (Intl.), Ltd.1980-09-09
MIDSTREAM COLLECTION KIT (K800947)Sage Products, Inc.1980-05-30
SPECIMEN COLLECTION PAN (K800309)Sage Products, Inc.1980-02-26
ABCO MIDSTREAM URINE COLLECTION SET (K800233)Abco Dealers, Inc.1980-02-26
PARA-PAK CLEAN VIAL (K792710)Meridian Diagnostics, Inc.1980-01-28
LANCER SPECIMEN CONTAINER (K792156)Sherwood Medical Co.1979-12-10
SPECIMAN CUP & EMESIS BASIN (K792211)General Clinical Plastics Corp.1979-11-16
JUHN TYM-TAP (K790915)Xomed, Inc.1979-06-27
OPERATING ROOM SPECIMEN CONTAINER (K790291)Sage Products, Inc.1979-04-10
24-HOUR URINE COLLECTION COOLING WRAP (K781557)Sage Products, Inc.1978-10-17
URINE SAMPLE COLLECTION KIT (K780057)C.R. Bard, Inc.1978-02-21
CATH KIT, URINE SPECIMEN (K780167)C.R. Bard, Inc.1978-02-21
SPECIMEN COLLECTION DEVICE (K780049)Urol, Inc.1978-01-26
UNICATCH (K770387)W.G. Whitney Corp.1977-04-05
MID-STREAM COLLECTION SET (K770231)Chesire Laboratories1977-03-30
SPECIMEN COLLECTOR (K770112)Portex, Inc.1977-03-14
4 1/2 OZ. GRADUATED SPECIMEN CONTAINER (K761191)Superior Plastic Products Corp.1977-02-28
CUP, DISPOSABLE SPECIMEN (K760496)Landmark Plastics1976-11-12

Track FMH automatically

Every clearance here is in the API, with alerts when new ones post.