Atlas FDA

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

Andersen Sterilizers, Inc. — Predicate Candidate Screening

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

259 daysmedian FDA review time
385 days90th percentile
19clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K213296Anprolene SteriTest RRBIAndersen Sterilizers, Inc.2022-04-121930
K202879EOGas 4 Endo-SteriTest RRBIAndersen Sterilizers, Inc.2021-03-031560
K192978EOGas 4 Ethylene Oxide Gas SterilizerAndersen Sterilizers, Inc.2020-11-123850
K200334AN1036 DosimeterAndersen Sterilizers, Inc.2020-11-122750
K192980EOGas 4 Endo-SteriTestAndersen Sterilizers, Inc.2020-11-123850
K200336Tyvek Sterilization Pouches with Chevron SealAndersen Sterilizers, Inc.2020-11-122750
K200335Sterisheet Sterilization WrapAndersen Sterilizers, Inc.2020-11-122750
K170437Sterisheet Sterilization WrapAndersen Sterilizers, Inc.2017-11-012610
K170439AN87 DosimeterAndersen Sterilizers, Inc.2017-11-012610
K170427Anprolene SteriTestAndersen Sterilizers, Inc.2017-10-312600
K170432Anprolene AN75 Ethylene Oxide Gas SterilizerAndersen Sterilizers, Inc.2017-10-312600
K170426AN85/AN86 EO IndicatorsAndersen Sterilizers, Inc.2017-10-302590
K170429Tyvek Sterilization Pouches with Chevron SealAndersen Sterilizers, Inc.2017-10-272560
K152291Sterisheet Sterilization WrapAndersen Sterilizers, Inc.2015-12-171260
K150645AN1087 DosimeterAndersen Sterilizers, Inc.2015-11-192520
K152058Tyvek Sterilization Pouches with Chevron SealAndersen Sterilizers, Inc.2015-11-181170
K150644AN85/AN86 EO IndicatorsAndersen Sterilizers, Inc.2015-11-182510
K150646EOGas 4 Ethylene Oxide Gas SterilizerAndersen Sterilizers, Inc.2015-11-182510
K151585Andersen EOGas 4 SteriTestAndersen Sterilizers, Inc.2015-11-181600

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