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

Cunningham Woodland, Inc. · Predicate Candidate Screening

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

17 daysmedian FDA review time
121 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K823527SUBCLAVIAN INSERTION KITCunningham Woodland, Inc.1983-03-311210
K813286PRE-PACK TENSCunningham Woodland, Inc.1982-01-22600
K813519NON-ABSORBENT TOWELSCunningham Woodland, Inc.1982-01-05200
K813284VENOUS CANNULA TRAYCunningham Woodland, Inc.1981-12-29360
K811091MINOR DRESSING TRAYCunningham Woodland, Inc.1981-05-08170
K811090MAJOR DRESSING TRAYCunningham Woodland, Inc.1981-05-08170
K811088DRESSING TRAY MERCY HOSPITALCunningham Woodland, Inc.1981-05-08170
K811089ONE STEP PREP KITCunningham Woodland, Inc.1981-05-08170
K811087MIKA SKIN SCRUB TRAY PRE OPERATIVE W/GELCunningham Woodland, Inc.1981-05-01100
K811086SUTURE REMOVAL SET(DISPLSABLE)Cunningham Woodland, Inc.1981-05-01100

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