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

Siemens Elema AB — Predicate Candidate Screening

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

76 daysmedian FDA review time

256 days90th percentile

63clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K023354	COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E	Siemens Elema AB	2003-09-05	333	1
K010923	KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E	Siemens Elema AB	2002-01-23	302	0
K010925	SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E	Siemens Elema AB	2001-12-18	266	1
K002137	CATHCOR DESKTOP	Siemens Elema AB	2000-10-05	83	1
K001315	MODIFICATION TO KION ANESTHESIA SYSTEM	Siemens Elema AB	2000-05-26	30	0
K970839	SERVO VENTILATOR 300A	Siemens Elema AB	1997-10-14	221	4
K960168	SIEMENS SERVO SCREEN 390 AND SERVO COMPUTER MODULE 990	Siemens Elema AB	1996-10-25	283	0
K960010	SERVO VENTILATOR 300 COMPUTER INTERFACE	Siemens Elema AB	1996-10-25	297	0
K872278	SIEMENS O2-AIR MIXER 965	Siemens Elema AB	1987-09-03	80	0
K871354	SERVO VENTILATOR 900 C/D	Siemens Elema AB	1987-07-21	106	0
K871829	SIEMENS DRY AIR COMPRESSOR	Siemens Elema AB	1987-06-15	35	0
K871366	SIEMENS MAIN FLOW BACTERIA FILTER	Siemens Elema AB	1987-05-14	37	0
K871293	SERVO NEBULIZER 945 SIEMENS-ELEMA AB	Siemens Elema AB	1987-05-08	38	0
K864105	LUNG MECHANICS SOFTWARE PROGRAM	Siemens Elema AB	1986-11-07	17	0
K863675	CALIBRATION GAS FOR SERVO GAS MONITOR 120	Siemens Elema AB	1986-11-03	45	0
K861707	MASTER PROGRAM FLOW & PRESSURE CO2 & LUNG MONITOR	Siemens Elema AB	1986-06-19	45	0
K861625	SERVO GAS MONITOR 120	Siemens Elema AB	1986-05-02	3	0
K854036	MANUAL VENTILATION ACCESSORY	Siemens Elema AB	1985-10-23	57	0
K852771	PC INTERFACE	Siemens Elema AB	1985-10-10	105	0
K852772	GAS EVACUATION ACCESSORY	Siemens Elema AB	1985-10-10	105	0
K852601	SERVO HUMIDIFIER 153	Siemens Elema AB	1985-07-08	19	0
K851044	CARDIOSTAT 3 RECORDER	Siemens Elema AB	1985-06-26	104	0
K850374	CONNECTION CABLE FOR SYNCHRONIZATION OF TWO SERVO	Siemens Elema AB	1985-04-25	84	0
K844392	CARDIOSTAT 1 ECG RECORDER	Siemens Elema AB	1985-04-11	149	0
K844912	SERVO VENTILATOR 900D SIEMENS-ELEMA AB	Siemens Elema AB	1984-12-28	10	0
K841225	PULSE GENERATOR 689, 689B & 689L	Siemens Elema AB	1984-12-03	256	0
K841230	PULSE GENERATOR 686, 686B 686L	Siemens Elema AB	1984-12-03	256	0
K841232	PULSE GENERATOR 696, 696B & 696L	Siemens Elema AB	1984-12-03	256	0
K844590	POWER PACK 160 SIEMENS-ELEMA AB	Siemens Elema AB	1984-11-29	3	0
K841227	BIPOLAR ENDOCARDIAL LEAD 406L	Siemens Elema AB	1984-11-27	250	0
K844040	SERVO HUMIDIFIER 152 SIEMENS-ELEMA AB	Siemens Elema AB	1984-10-25	9	0
K843440	MINGO LOG 7	Siemens Elema AB	1984-09-04	0	0
K841233	PULSE GENERATOR 678L	Siemens Elema AB	1984-07-06	106	0
K841231	PULSE GENERATOR 688B & 688L	Siemens Elema AB	1984-06-26	96	0
K841228	PULSE GENERATOR 718B & 718L	Siemens Elema AB	1984-06-26	96	0
K841226	PULSE GENERATOR 728, 728B & 728L	Siemens Elema AB	1984-06-26	96	0
K841229	PULSE GENERATOR 698, 698B & 698L	Siemens Elema AB	1984-06-25	95	0
K840326	GAS SUPPLY MANIFOLD SIEMENS-ELEMA AB	Siemens Elema AB	1984-06-07	134	0
K841157	HALOTHANE VAPORIZER 950, ENFLURANE	Siemens Elema AB	1984-06-07	80	0
K841657	PATIENT TUBING HYTREL SIEMENS-ELEMA	Siemens Elema AB	1984-05-23	30	0
K841529	SIEMENS-ELEMA VENTILATOR 900C	Siemens Elema AB	1984-05-23	40	0
K841393	AB MANUAL VENTILATION ACCESS. 900C	Siemens Elema AB	1984-05-21	48	0
K840264	SERVO CART 170	Siemens Elema AB	1984-02-04	12	0
K832898	NEBULIZER ACCESSORY FOR SERVO VENTILL	Siemens Elema AB	1983-11-25	91	0
K832959	PACEMAKER SYS. ANALYZER 378	Siemens Elema AB	1983-11-14	76	0
K822213	SIEMENS-ELEMA AB AGA REVIVATOR	Siemens Elema AB	1982-10-28	94	0
K820657	PULSE GENERATOR 678 B	Siemens Elema AB	1982-04-15	37	0
K820767	BIOPOLAR TINED ENDOCARDIAL LEAD 403B/60	Siemens Elema AB	1982-04-09	18	0
K813576	SIEMENS-ELEMA PULSE GENERATOR 659	Siemens Elema AB	1982-01-22	30	0
K811102	SIEMENS-ELEMA AB SERVO VENTILATOR 900 C	Siemens Elema AB	1981-05-05	14	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