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

Instrumentarium Corp. · Predicate Candidate Screening

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

74 daysmedian FDA review time

374 days90th percentile

20clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K022630	MODIFICATION TO FOCUS	Instrumentarium Corp.	2002-10-09	63	1
K001729	FOCUS	Instrumentarium Corp.	2000-07-13	36	0
K001439	ORTHOCEPH OC100 D	Instrumentarium Corp.	2000-06-22	45	0
K992385	ORTHOPANTOMOGRAPH OP100D	Instrumentarium Corp.	1999-09-28	74	0
K981641	MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA	Instrumentarium Corp.	1998-07-17	70	0
K962638	TONOCAP, TC-200 AND ACCESSORY CATHETERS	Instrumentarium Corp.	1997-04-04	273	0
K961441	TONOMETERED SLAINE BLOOD GAS CONTROL	Instrumentarium Corp.	1996-04-30	15	0
K955018	TRIP NGS & SIGMOID CATHETER PHI SLIDE CALCULATOR	Instrumentarium Corp.	1996-01-30	89	0
K934478	ALPHA STEREO	Instrumentarium Corp.	1995-01-31	504	0
K923433	AS/3 ANAESTHESIA MONITORING SYSTEM AIRWAY MODULE	Instrumentarium Corp.	1993-07-22	374	0
K930338	ORTHOCEPH OC100	Instrumentarium Corp.	1993-04-27	92	0
K912893	ORTHOPANTOMOGRAPH 100	Instrumentarium Corp.	1991-11-05	127	0
K904355	CARDIOCAP II TM CH-RESP MONITORS	Instrumentarium Corp.	1991-05-23	241	0
K883621	INSTRUMENTARIUM ULF MR IMAGING SYSTEM	Instrumentarium Corp.	1988-11-10	77	0
K883649	INSTRUMENTARIUM ULF MR IMAGING SYSTEM MODEL 110H	Instrumentarium Corp.	1988-10-19	51	0
K883650	INSTRUMENTARIUM ULF MR IMAGING SYSTEM VERSION 110	Instrumentarium Corp.	1988-09-16	18	0
K883622	INSTRUMENTARIUM ULF MR IMAGING SYSTEM	Instrumentarium Corp.	1988-09-14	20	0
K853953	CARDIOCAP MONITOR	Instrumentarium Corp.	1986-06-02	250	0
K853396	MULTICAP MULTIGAS CAPNOMETER PB252	Instrumentarium Corp.	1985-08-16	4	0
K833739	CD-102 CARBON DIOXIDE ANALYZER/RECOR	Instrumentarium Corp.	1983-12-16	52	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