Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Pymah Corp. — Predicate Candidate Screening

17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

89 daysmedian FDA review time
459 days90th percentile
17clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K952995ATI ETHYLENE OXIDE STERILIZATION INDICATORPymah Corp.1996-02-222390
K952408ATI DISPOSABLE TEST PACK FOR STEAM STERILIZATIONPymah Corp.1995-07-06450
K951063ATI DISPOSABLE TEST PACK FOR EO GAS STERILIZATIONPymah Corp.1995-05-10630
K934874STERIGAGE EO 100%Pymah Corp.1995-04-185530
K943081TRIMLINE 2000Pymah Corp.1995-01-272130
K925496ATI DISPOSABLE BIOLOGICAL-PLUS TEST PACKPymah Corp.1994-02-014590
K925745ATI(R) DISP BIOLOGICAL-PLUS TEST PACKPymah Corp.1994-02-014450
K934180SLIMLINE 3000Pymah Corp.1993-11-24890
K924681GLUTARALDEHYDE MONITORSPymah Corp.1993-11-174270
K925744TEMPA-KUFF SINGLE PAT PRE-GAGED BALANCED DISP CUFFPymah Corp.1993-07-302590
K930604BALANCED(TM) NYLON BLADDERPymah Corp.1993-04-30840
K915170PYMAH COLD STERILOG GLUTARALDEHYDE MONITORPymah Corp.1992-07-282560
K903379PYMAH PRE-GAGED BALANCED TEMPA-KUFFPymah Corp.1990-10-19810
K894398STERIGAGE INTEGRATOR TEST PACK FOR ETHYLENE OXIDEPymah Corp.1989-09-11560
K894399STERIGAGE INTEGRATOR TEST PACK FOR STEAM STERILI.Pymah Corp.1989-09-11560
K884421PRE-GAGED BALANCED CUFF W/SYLGARD ANTIMICRO. TREATPymah Corp.1989-01-13850
K881286TEMPA-DOT CLINICAL THERMOMETER SHEATHPymah Corp.1988-06-08750

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