Keeler Instruments, Inc.

Broomall, PA, US

Keeler Instruments, Inc. appears in FDA device records in Broomall, PA. FDA records list 60 510(k) clearances between 1981-06-23 and 2019-02-08, no PMA records and no registered establishments. As of 2026-09-10, FDA records show one recall for this company.

510(k) clearances: 60
PMA records: 0
Recall records: 1
Registered establishments: 0

510(k) clearance history

Showing 50 of 60

FDA records hold 60 510(k) clearances for Keeler Instruments, Inc. between 1981 and 2019. The busiest year on record is 1986, with 14. The most recent is 2019, with 1.

Clearances by year, as a table

510(k) clearance decisions for Keeler Instruments, Inc., by decision year
Year	Clearances
1981	2
1983	2
1984	2
1985	10
1986	14
1987	4
1988	3
1989	7
1990	1
1991	1
1992	1
1994	2
1997	1
1998	1
1999	2
2003	1
2006	2
2010	2
2011	1
2019	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K181143	Keeler TonoCare Tonometer	HKX	Substantially Equivalent	2019-02-08
K112093	CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER	HRN	Substantially Equivalent	2011-12-08
K093298	PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000	HKX	Substantially Equivalent	2010-12-10
K100500	PSL CLASSIC SLIT LAMP	HJO	Substantially Equivalent	2010-03-09
K062412	CRYOMATIC	HRN	Substantially Equivalent	2006-11-06
K060822	VANTAGE INDIRECT OPHTHALMOSCOPE	HLI	Substantially Equivalent	2006-05-23
K032087	KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004	HLJ	Substantially Equivalent	2003-11-26
K992954	KEELER CRYO MASTER & PROBES	HRN	Substantially Equivalent	1999-12-21
K990257	KEELER PULSAIR 3000 NON CONTACT TONOMETER	HKX	Substantially Equivalent	1999-03-25
K973064	KEELER TEARSCOPE-PLUS	HJO	Substantially Equivalent	1998-04-07
K970029	KEELER SPECTRA INDIRECT OPHTHALMOSCOPE	HLJ	Substantially Equivalent	1997-04-02
K942180	KEELER MULTILASE 3000	HQF	Substantially Equivalent	1994-11-22
K942104	KEELER VANTAGE INDIRECT OPHTHALMOSCOPE	HLI	Substantially Equivalent	1994-08-04
K914956	KEELER KONAN SPECULAR MICROSCOPE SP5500	HRM	Substantially Equivalent	1992-02-03
K911721	KEELER PULSAIR NON CONTACT TONOMETER, MODIFICATION	HKX	Substantially Equivalent	1991-06-25
K900111	KEELER KONAN SPECULAR MICROSCOPE SP3300	HLI	Substantially Equivalent	1990-03-23
K895213	MICROLASE BY LASER TRABECULOPLASTY	HQF	Substantially Equivalent	1989-10-31
K893171	VISTA STREAK RETINOSCOPE (AC-POWERED)	HKL	Substantially Equivalent	1989-09-21
K893173	VISTA SPECIALIST OPHTHALMOSCOPE (BATTERY & AC)	HLI	Substantially Equivalent	1989-06-05
K893172	VISTA OPHTHALMOSCOPE (BATTERY AND AC-POWERED)	HLI	Substantially Equivalent	1989-06-05
K893170	VISTA FINOFF TRANSILLUMINATOR (AC-POWERED)	HJM	Substantially Equivalent	1989-06-05
K891610	HENSON CFA 3000 CENTRAL VISUAL FIELD SCREENER	HOD	Substantially Equivalent	1989-06-05
K890086	MICROLASE 8 0 0 (OPHTHALMIC LASER)	HQF	Substantially Equivalent	1989-03-15
K882772	LQ1106 OPHTHALMIC YAG LASER	GEX	Substantially Equivalent	1988-08-26
K874555	KEELER ACU 22XT OPHTHALMIC CRYO UNIT	HPS	Substantially Equivalent	1988-01-29
K874411	DONALDSON NATURAL EYEPATCH 'PATIENT PAK'	HMP	Substantially Equivalent	1988-01-27
K873388	KEELER CTU CRYO SYSTEM	HPS	Substantially Equivalent	1987-11-13
K871369	VARIOUS TYPES OF: KEELER MAGNATONE 2 STETHOSCOPES:	LDE	Substantially Equivalent	1987-09-24
K870750	KEELER PULSAIR NON CONTACT TONOMETER	HKX	Substantially Equivalent	1987-03-17
K870203	KEELER LVA SYSTEM MULTI-CAP SERIES LVA51-1/2/3/4/5	HKK	Substantially Equivalent	1987-02-12
K864467	HENSON - HAMBLIN CFS 2000 CENTRAL FIELD SCREEN	HOO	Substantially Equivalent	1986-12-15
K864290	RK-M & RK-DK DIAMOND KNIVES WITH MEASURING GAUGE	HNN	Substantially Equivalent	1986-12-15
K863992	THORNTON TITANIUM FORCEPS (VARIOUS TYPES)	HNR	Substantially Equivalent	1986-10-31
K863991	THORTON TITANIUM NEEDLEHOLDERS(NO,W CATCH & STAND	HNR	Substantially Equivalent	1986-10-31
K863990	THORNTON TITANIUM SILVER SPATULA	HND	Substantially Equivalent	1986-10-31
K863989	THORNTON TITANIUM SPECULUM (MODIFIED BARRAQUER)	HNC	Substantially Equivalent	1986-10-31
K863988	THORTON TITANIUM HOOK ANGLED RIGHT	HNQ	Substantially Equivalent	1986-10-31
K861747	KEELER FIBEROPTIC HEADLAMP	HPQ	Substantially Equivalent	1986-08-21
K861746	KEELER DUAL LIGHTSOURCE	HPQ	Substantially Equivalent	1986-08-21
K861744	SAPPHIRE KNIFE BLADE	HNN	Substantially Equivalent	1986-06-09
K861748	RUBY & SAPPHIRE BLADE HOLDER	HNN	Substantially Equivalent	1986-06-02
K861749	3X BLUE PANORAMIC LOUPES 13.5 WORKING DISTANCE	FSP	Substantially Equivalent	1986-05-23
K861745	VICKERS ERGOMATIC MICROSURG INSTRU CARDIAC SET	DWS	Substantially Equivalent	1986-05-13
K860979	DONALDSON NATURAL EYEPATCH	HMP	Substantially Equivalent	1986-04-04
K854422	SERIES 25 SLIMLINE CRYO PROBES	HQA	Substantially Equivalent	1985-12-30
K854411	KEELER-COMPACT CRYO SYSTEM	HQA	Substantially Equivalent	1985-12-30
K854440	MODIFIED CLINICAL WIDEFIELD SPECULAR MICROSCOPE 50	HRM	Substantially Equivalent	1985-12-16
K854256	KEELER AMOILS SURGICAL ASTIGOMETER		Substantially Equivalent	1985-12-13
K854244	THE KEELER ALL PUPIL INDIRECT OPHTHALMOSCOPE	HLI	Substantially Equivalent	1985-11-12
K853179	VICKERS ERGOMATIC MICROSUR INSTRU-UNIV R O L HAND	GZX	Substantially Equivalent	1985-11-07

Registered establishments

No FDA establishment registrations recorded against this company.

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-1132-2008	Keeler All Pupil II Indirect Ophthalmoscope, Keeler Instruments, Inc., Broomall, PA 19008	Good Manufacturing Practices (GMP) deficiencies may compromise the safety and effectiveness of the device. Firm is on import alert 89-04 and released product.		2008-01-08	Terminated

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Keeler Instruments, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain