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

Kelleher Corp. — Predicate Candidate Screening

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

29 daysmedian FDA review time

76 days90th percentile

94clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K822268	NAGASHIMA NS-III ELECTRONYSTAGMOGRAPH	Kelleher Corp.	1983-01-28	183	0
K822618	EMERGENCY TRACHEOSTOMY INSTRUMENT SET	Kelleher Corp.	1983-01-28	148	0
K823083	ELECTROSURGICAL UNIT	Kelleher Corp.	1982-12-07	49	0
K823111	NYSTYMOGRAPH ACCESS	Kelleher Corp.	1982-11-22	28	0
K822252	ENT TREATMENT UNITS	Kelleher Corp.	1982-11-22	116	0
K822272	HEAD MIRRORS W/HEAD LAMPS & HEAD BANDS	Kelleher Corp.	1982-11-10	104	0
K822017	TYMPANOSTOMY TUBES & VARIOUS TYPES	Kelleher Corp.	1982-10-27	111	0
K822257	VARIOUS TYPES OF LIGHT SOURCE HANDLES	Kelleher Corp.	1982-10-26	89	0
K822259	LARYNGEAL SPATULAS	Kelleher Corp.	1982-10-22	85	0
K822004	FACE SHIELDS	Kelleher Corp.	1982-10-20	104	0
K822185	LARYNGEAL SYRINGE	Kelleher Corp.	1982-10-18	87	0
K822267	TRANSFORMER	Kelleher Corp.	1982-10-13	76	0
K822264	NAGASHIMA SN OPERATOR'S CHAIR	Kelleher Corp.	1982-10-13	76	0
K822201	EAR CANNULAS	Kelleher Corp.	1982-10-06	75	0
K822569	TYMPANOPLASTY & SKIN DISSECTORS	Kelleher Corp.	1982-10-06	43	0
K822265	FIBEROPTIC LIGHT SOURCE W/RELATED ITEMS	Kelleher Corp.	1982-09-28	61	0
K822179	FRENZEL EYEGLASSES & RELATED ITEMS	Kelleher Corp.	1982-09-21	60	0
K822204	ENT MALLETS	Kelleher Corp.	1982-09-17	56	0
K822566	AURAL REFLEX INDICATOR	Kelleher Corp.	1982-09-14	21	0
K822351	POWDER BLOWERS	Kelleher Corp.	1982-09-14	39	0
K822568	EAR PROBES	Kelleher Corp.	1982-09-14	21	0
K822016	NAGASHIMA SN-SP UNIT AND CHAIR	Kelleher Corp.	1982-09-14	68	0
K822523	LARYNGOSTROBOSCOPE	Kelleher Corp.	1982-09-09	17	0
K822525	LARYNGOSCOPES RIGID	Kelleher Corp.	1982-09-09	17	0
K822269	NAGASHIMA SN SOUND-PROOF CHAMBER-HEARING	Kelleher Corp.	1982-09-09	42	0
K822524	EAR SPOON	Kelleher Corp.	1982-09-09	17	0
K822260	TRACHEAL DILATORS	Kelleher Corp.	1982-09-02	35	0
K822273	ENT CURRETTES	Kelleher Corp.	1982-08-30	32	0
K822280	ENT KNIFE HANDLES	Kelleher Corp.	1982-08-30	32	0
K822205	KNIVES, ENT	Kelleher Corp.	1982-08-30	38	0
K822282	FIBEROPTIC LIGHT CARRIERS	Kelleher Corp.	1982-08-30	32	0
K822274	MYLE'S GUILLOTINE	Kelleher Corp.	1982-08-30	32	0
K822261	LARYNGEAL MIRRORS	Kelleher Corp.	1982-08-30	32	0
K822196	EAR SCISSORS	Kelleher Corp.	1982-08-30	38	0
K822181	BINOCULAR OPER. MICROSCOPES & ACCESSOR	Kelleher Corp.	1982-08-27	35	0
K822194	ENDOSCOPIC SPONGE CARRIER	Kelleher Corp.	1982-08-27	35	0
K822251	EXAMINATION & TREATMENT CHAIRS	Kelleher Corp.	1982-08-27	29	0
K822278	ENT FORCEPS	Kelleher Corp.	1982-08-27	29	0
K822277	ROSEN'S STAPES NEEDLE EXPLORER	Kelleher Corp.	1982-08-25	27	1
K822255	RIGID SUCTION TIPS	Kelleher Corp.	1982-08-25	27	0
K822258	ESOPHAGEAL BOUGIES	Kelleher Corp.	1982-08-25	27	0
K822177	AUDIOMETERS (VARIOUS MODELS)	Kelleher Corp.	1982-08-25	33	0
K822199	EAR SNARES	Kelleher Corp.	1982-08-25	33	0
K822279	LANCETS FOR EAR SURGERY	Kelleher Corp.	1982-08-25	27	0
K822186	MACKENZIE'S TONSILLECTOME	Kelleher Corp.	1982-08-25	33	0
K822262	ADENOTOMES	Kelleher Corp.	1982-08-25	27	0
K822253	RASPS	Kelleher Corp.	1982-08-25	27	0
K822198	MALLEUS NIPPERS	Kelleher Corp.	1982-08-25	33	0
K822195	MIRCOSURGICAL INSTRUMENTS	Kelleher Corp.	1982-08-25	33	0
K822187	TONSIL DISSECTORS	Kelleher Corp.	1982-08-24	32	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