Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
ILQ · Predicate Candidate Screening
38 FDA 510(k) clearances under this product code; the 50 most recent screened below.
37 daysmedian FDA review time
205 days90th percentile
38clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K162817 | Noddle(TM) | Iowa Adaptive Technologies, Inc. Dba Voxello, Inc. | 2017-01-18 | 104 | 0 |
| K943035 | P.A.T. SYSTEM | Mathews Assoc., Inc. | 1994-10-04 | 99 | 0 |
| K930044 | COMFORT KEYBOARD SYSTEM | Health Care Keyboard Co., Inc. | 1994-07-14 | 555 | 0 |
| K931855 | LIGHTWRITER | Zygo Corp. | 1994-05-10 | 392 | 0 |
| K935244 | R & D BATTERIES, INC. PART NUMBER 5113 | R & D Batteries, Inc. | 1994-04-19 | 169 | 0 |
| K935981 | MLT-2 | Med Labs, Inc. | 1994-02-17 | 65 | 0 |
| K925387 | LIBERATOR | Prentke Romich Co. | 1993-03-29 | 154 | 0 |
| K925527 | LIGHT TALKER | Prentke Romich Co. | 1993-03-22 | 140 | 0 |
| K924030 | SCRIBE | Zygo Industries, Inc. | 1993-03-04 | 205 | 0 |
| K924014 | SECRETARY | Zygo Industries, Inc. | 1993-03-04 | 205 | 0 |
| K924015 | PARROT | Zygo Industries, Inc. | 1993-03-04 | 205 | 0 |
| K924013 | MACAW | Zygo Industries, Inc. | 1993-03-04 | 205 | 0 |
| K923819 | EEC-1 PACKAGE | Med Labs, Inc. | 1992-11-06 | 99 | 0 |
| K914259 | TOUCH TALKER | Prentke Romich Co. | 1992-02-27 | 157 | 0 |
| K914103 | LIFELINE(R) PERSONAL RESPONSE SYSTEM | Lifeline Systems, Inc. | 1991-09-27 | 15 | 3 |
| K910796 | COMPANION SPEECH AID, MODEL 432 | Companion Products Intl. | 1991-03-07 | 9 | 0 |
| K910819 | COMPANION SPEECH AID, MODEL 160 | Companion Products Intl. | 1991-03-07 | 9 | 0 |
| K905474 | THE EYEGAZE SYSTEM | Lc Technologies, Inc. | 1991-02-28 | 84 | 0 |
| K905576 | LINGRAPHICA VISUAL LANGUAGE PROSTHESIS | Tolfa Corp. | 1990-12-31 | 19 | 0 |
| K904796 | MEDICAL ALERT SYSTEM, MODEL 2200 & 4400 V/T | Personal Emergency Response System | 1990-11-26 | 34 | 0 |
| K903605 | CINTEX | Nanopac, Inc. | 1990-09-14 | 37 | 0 |
| K903652 | SCAN COM AND SCAN COM P (TENTATIVE) | Med Labs, Inc. | 1990-08-24 | 11 | 0 |
| K902206 | CONTROL 1 ENVIRONMENTAL CONTROL | Prentke Romich Co. | 1990-05-29 | 13 | 0 |
| K901030 | ROTARY COMMUNICATION SCANNER MODEL 7010 | Baylor Biomedical Services | 1990-03-13 | 7 | 0 |
| K901029 | YES-NO VOICE BOX 7011 | Baylor Biomedical Services | 1990-03-13 | 7 | 0 |
| K893473 | COMMUNI-CALL | Carepartners, Inc. | 1989-06-09 | 36 | 0 |
| K864204 | VOCAID, ELECTRONIC VOCAL AID | Texas Instruments, Inc. | 1986-11-14 | 18 | 0 |
| K863995 | KEYNOTE | Sensory Aids Corp. | 1986-11-13 | 30 | 0 |
| K842535 | PENTAD VOCALIZER | Pentad Corp. | 1984-07-13 | 15 | 0 |
| K841528 | CONVAID - SPEECH AID | Convaid , Ltd. | 1984-05-09 | 27 | 0 |
| K831093 | APELLO, PERSONAL HEALTH SUPPORT SYS. | Almicro Electronics, Inc. | 1983-05-16 | 42 | 0 |
| K821677 | THE COMMUNICATOR | Robert Swinney. , Ltd. | 1982-06-22 | 14 | 0 |
| K812720 | BODAI PATIENT COMMUNICATOR | Sontek Industries, Inc. | 1981-11-05 | 41 | 0 |
| K802687 | SPEAKEASY COMMUN. SYSTEM-COMM. PROTHESIS | Intelligent Software Systems, Inc. | 1981-02-04 | 98 | 0 |
| K771825 | CARBA LINGUARDUC | C.R. Bard, Inc. | 1977-10-06 | 9 | 0 |
| K770031 | ALARM INTERCOM DOOR LOCK | Possum, Inc. | 1977-01-12 | 6 | 0 |
| K770030 | ALARM, COMMUN.-SEC. INDEP.-EMER. | Possum, Inc. | 1977-01-12 | 6 | 0 |
| K770029 | TYPEWRITER CONTROL SYSTEMS | Possum, Inc. | 1977-01-12 | 6 | 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