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

Kyphon, Inc. — Predicate Candidate Screening

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

57 daysmedian FDA review time

189 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K073516	DISCYPHOR DIRECT CATHETER SYSTEM, DISCYPHOR DIRECT NEEDLES,	Kyphon, Inc.	2008-02-21	69	0
K063071	DISCYPHOR CATHETER SYSTEM, MODEL D01A; DISCYPHOR INTRODUCER	Kyphon, Inc.	2007-04-13	189	0
K061210	FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) CATHETER SYSTEM, MO	Kyphon, Inc.	2006-06-27	57	0
K041454	KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A	Kyphon, Inc.	2004-07-09	38	2
K041584	KYPHX HV-R BONE CEMENT, MODEL C01A	Kyphon, Inc.	2004-07-07	23	2
K033801	KYPHX HV-R, MODEL C01A	Kyphon, Inc.	2004-04-01	115	2
K032212	KYPHX DIRECTIONAL INFLATABLE BONE TAMP, MODELS K16A AND K17A	Kyphon, Inc.	2003-09-15	56	0
K010246	KYPHX INFLATABLE BONE TAMP, SIZE 20/3,MODEL K01A, KYPHX INFL	Kyphon, Inc.	2001-02-14	19	0
K981251	KYPHON INFLATABLE BONE TAMP	Kyphon, Inc.	1998-07-02	87	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